Post on 13-Mar-2020
Block- and schedule placement of elective courses
Elective courses offered to BA (bachelor) and KA (master) students are marked with green. Elective courses only for KA students are marked with blue. Elective courses only for BA students are marked with orange. The number and level of students are given in brackets including reserved seats for students at specific educations (MPS: Master in Pharmaceutical Sciences, MedChem: Master in Medicinal Chemistry, BA chemistry: Bachelor in Chemistry with specialization in Medicinal Chemistry).
Autumn 2018
Block 1 Block 2
A Pharmaceutical modelling Theories and Research Methods in
Social Clinical Pharmacy
Pharmacokinetics and pharmacodynamics
Klinisk Farmaci B
Advanced manufacturing of pharmaceuticals
Biopharmaceuticals: Formulation of peptides and proteins
Methods and procedures in clinical drug development
C Principles and practice of bioanalysis Biopharmaceutics: Aspects of drug
delivery systems design
Biopharmaceuticals: Design and modifications of biomacromolecules
In vitro techniques in biochemistry and pharmacology
Block 3 Block 4
A Pharmacotherapy Practice Intellectual Property Rights and Innovation in Pharmaceutical Sciences
Design, synthesis and reactivity in medicinal and biopharmaceutical chemistry
Contemporary social pharmacy
Advance in Medicinal Chemistry Research
B Design and Analysis of Experiments Radiopharmaceutical Chemistry
Molecular pharmacology Characterization of drug substances and drug delivery systems
Entrepreneurship in pharmaceuticals
C Drug delivery to the central nervous system (CNS)
Neuropharmacology
Pharmacoepidemiology and pharmacovigilance
Computational Medicinal Chemistry
Regulatory Science
Spring 2019
Autumn 2019
Biopharmaceuticals: Protein production and analysis
Blok-og skemagruppeplacering af obligatoriske kandidatkurser i efterår 2018 og foråret 2019 Obligatoriske KA kurser
Block 3 Block 4
A Pharmaceutical Analytical Chemistry (MPS line II)
Research Project in Pharmaceutics and Drug Delivery (15 ECTS MPS line II)
Pharmacology from Physiology to Therapy (15 ECTS MPS line I and III)
B Pharmacology from Physiology to Therapy (15 ECTS MPS line I and III)
Research Project in Pharmaceutics and Drug Delivery (15 ECTS MPS line II)
C Research Project in Pharmaceutics and Drug Delivery (15 ECTS MPS line II)
Obligatoriske KA kurser
Block 1 Block 2
A Pharmaceutical Policy (KA i Farmaci og Farmaceutisk Videnskab)
Advanced Pharmaceutics (KA i Farmaci og Farmaceutisk Videnskab)
Principles of Pharmacology (MPS) Pharmaceutics and drug development (MPS)
B Toxicology and drug safety (KA i Farmaci og Farmaceutisk Videnskab)
Medicinal and biostructural chemistry (alle KA uddannelser på PharmaSchool)
Drug Discovery and development (MPS)
C Pharmaceutics and drug development (MPS)
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige version.
TEMP0009 Advanced Pharmaceutics
Expand all Volume 2018/2019
Education
MSc Programme in Pharmacy and Pharmaceutical Sciences - compulsory
MSc Programme in Medicinal Chemistry - elective
MSc Programme in Pharmaceutical Sciences (english programme) - elective
Content
The course gives an overview on fundamental principles in advanced pharmaceutics. Advanced
pharmaceutics topics, which will be addressed in the course, encompass (i) release mechanisms,
(ii) pharmaceutical nanotechnology, (iii) biopharmacy, and (iv) manufacturing and quality control
of advanced dosage forms. The first theme covers release mechanisms. This includes immediate
release, controlled release, and targeted and triggered release of drugs. Pharmaceutical
nanotechnology (theme ii) is addressing drug-polymer conjugates, delivery of biopharmaceuticals
(peptides, proteins and nucleic acids), advanced drug delivery systems and delivery of vaccines.
The third theme of the course (biopharmacy) will focus on evaluation of oral dosage forms,
alternative administration routes for delivery of peptides and proteins, and aspects related to the
drug development process in general (decision trees in drug development, PKPD modelling,
regulatory requirements, the Biopharmaceutics Risk Assessment Road Map, personalized drug
delivery, precision medicine and patient centric therapy). The course will also discuss
manufacturing and quality control (theme iv). This includes manufacturing and analytical aspects
of advanced dosage forms, continuous manufacturing, and quality control aspects of advanced
dosage forms.
The overall aim of the course is to prepare the students to be able to select an advanced dosage
form for a given drug, based on knowledge about the physicochemical properties of the drug, the
advanced dosage form and the administration route. In addition, the student should be able to
select methods for manufacturing, evaluation and quality control of advanced dosage forms.
Learning Outcome
At the end of this course, students are expected to be able to:
Knowledge
• Explain, define and summarize current advanced pharmaceutics principles
• Know and have an overview of current advanced pharmaceutics
Skills
• Able to critically identify, discuss and generalize the knowledge gained in advanced
pharmaceutics
• Master the scientific methodologies in the field of advanced pharmaceutics
• Retrieve, assess and debate information on advanced dosage forms
• Communicate complex theoretical knowledge and experimental data
Competences
• Take responsibility and develop lifelong learning skills on advanced dosage forms
• Fundamentally understand the drug development process and the factors that have to be
considered
Literature
Aulton´s Pharmaceutics (AP)
Pharmaceutics, Drug Delivery and Targeting (PDDT)
Selected review articles and original scientific papers
Formal requirements
non.
Recommended Academic Qualifications
A Bachelor in Pharmacy.
The course are organized under the assumption that the courses Pharmaceutics 1 and
Pharmaceutics 2 or similar have been completed.
Teaching and learning methods
The lectures are based on text books, selected review articles and original scientific papers. The
main teaching forms will be lectures, class room teaching, supervised group work and student
presentations. The group work will be based on individual cases of a selected topic of advanced
pharmaceutics. Students will be divided into groups of 4-6 students, and each group will be given
an assignment. The groups meet with the responsible lecturer twice during the group work
period to discuss the group work and to prepare the groups for their presentations. In addition,
the students will be taught in “How to prepare a scientific presentation (oral + poster)” via class
room teaching. The group work will be presented by the students ad either oral or poster
presentations, presented at two conference-style full-day workshops at the end of the block
(referred to as “Conference Day 1 and 2”).
Lectures (16 double lectures)
Classroom teaching (1 lecture)
Supervised groupwork on individual cases
Student presentations
Feedback form
Oral
Individual
Collective
Continuous feedback during the course of the semester
Peer feedback (Students give each other feedback)
Sign up
Self Service at KUnet
Open for credit transfer students and other external students. Apply here:
Credit transfer students:
http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/
Other external students:
http://healthsciences.ku.dk/education/exchange_guest_students/guest-students/
Credit transfer and other external students are welcomed on the course if there are seats available and they have the academic qualifications.
Exam (Continuous assessment)
Credit
7,5 ECTS
Type of assessment
Continuous assessment, 1 hour online per double lecture, ongoing throughout course
Practical oral examination, 16 h under invigilation
Continuous assessment, 1 hour online per double lecture, ongoing throughout the course.
After every double lecture, a set of questions (MCQ) will be made available. The students need to
answer the questions and will be graded as "passed" or "non-passed" Not filling in in time is
"non-passed". At least 80% of the tests have to be passed to pass the course. A single test is
passed when more than 80% is answered correctly.
Student assessment within the group work: Each student will be assessed according to the
following criteria: A) Each student in a group has contributed equally to the group work. B) The
group work has been submitted and presented at Conference Day 1 or 2. C) Each student has
fully attended Conference Day 1 and 2. Each student has actively participated (either in
presentation or as opponent) on Conference Day 1 or 2. Students have passed the group work
assessment only if ALL assessments criteria have been fulfilled.
Exam registration requirements Aid
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Re-exam
Students have to pass all examination parts in order to pass the course. Failing in any part will
lead to the students having to write a comprehensive report on a subject determined by the
course responsible, followed by an oral exam on the entire course content.
Criteria for exam assesment
To achieve a course certificate the students must be able to:
Knowledge
• Explain, define and summarize current advanced pharmaceutics principles
• Know and have an overview of current advanced pharmaceutics
Skills
• Able to critically identify, discuss and generalize knowledge gained in advanced
pharmaceutics
• Master the scientific methodologies in the field of advanced pharmaceutics
• Retrieve, assess and debate information on advanced dosage forms
• Communicate complex theoretical knowledge and experimental data
Competences
• Take responsibility and develop lifelong learning skills on advanced dosage forms
• Fundamentally understand the drug development process and the factors that have to be
considered
Workload
Category Hours
Exam 16
Lectures 32
Preparation 64
Class Instruction 1
Project work 77
Colloquia 16
Total 206
Course information
Language
English
Course code
TEMP0009
Credit
7,5 ECTS
Level
Full Degree Master
Duration
1 block
Placement
Block 2
Schedule
A
Inklusiv fredag i uge 8.
Course capacity
230 students
Continuing and further education Study board
Study Board of Pharmaceutical Sciences
Contracting department
Department of Pharmacy
Course Coordinators
Thomas Rades (thomas.rades@sund.ku.dk)
Hovedansvarlig
Camilla Foged (camilla.foged@sund.ku.dk)
Lecturers
Thomas Rades
Camilla Foged
Jukka Rantanen
Anette Müllertz Saved on the 02-01-2018
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige version.
TEMP141202 Biopharmaceutics: Aspects of Drug
Delivery System Design
Expand all Volume 2018/2019
Education
MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and
cand.scient.pharm) - elective
MSc Programme in Medicinal Chemistry - elective
MSc Programme in Pharmaceutical Sciences (English programme) - elective
Content
The course addresses in detail the aspects of biopharmaceutics in drug delivery.
This includes consideration of not only the drugability of a specific drug molecule for reaching a
specific target, but also links to the developability in relation to the design of a desired drug
delivery system.
Biopharmaceutical aspects are here defined as the interrelation of the drug/drug delivery system
with biological matrices (e.g. blood, saliva, gastro-intestinal fluids, lung-lining fluids, mucus,
epithelia, endothelia) and how this may influence delivery of the drug to exert the desired effect
effects on PK and PD).
Delivery of sufficient amounts of the active pharmaceutical ingredient (API) to therapeutic targets
increasingly require the use of biopharmaceuticals (i.e. peptides, proteins, nucleic acids), but also
small molecule drugs. Combination therapies and/or the application of functionalizing excipients
and drug delivery systems.
The course will in a case-based manner focus on how to asses and in-depth evaluate drug
delivery systems towards a translation from molecule to dosage form.
The course will be be class-room lectures (16x2 lectures; e.g. Tuesdays and Thursdays 8-10)
supplemented with group work and presentations by the students.
Learning Outcome
At the end of the course, students are expected to be able to:
Knowledge
• identify and explain biopharmaceutical aspects in drug research and development (i.e. be
able to consider drugability and developability of drugs/drug delivery systems)
• refere state-of-the-art methodologies for assessment of biopharmaceutical aspects in drug
delivery
Skills
• select and use relevant scientific information in relation to planning and executing the
biopharmaceutical evaluation of a given drug/drug delivery system
• plan, prepare and present (examples of) laboratory protocols
• evaluate experimental data and relate to findings
Literature
1) selected text book material/chapters
2) scientific literature
3) experimental data and protocol examples
Formal requirements
Non.
Teaching and learning methods
Lectures, supervised group work and student presentations (written/oral) with peer-reviewing
Feedback form
Oral
Continuous feedback during the course of the semester
Peer feedback (Students give each other feedback)
Sign up
Self Service at KUnet
Open for credit transfer students and other external students. Apply here:
Credit transfer students:
http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/
Other external students:
http://healthsciences.ku.dk/education/exchange_guest_students/guest-students/
Exam (Continuous assessment)
Credit
7,5 ECTS
Type of assessment
Continuous assessment
To obtain a course certificate the students should:
*Take part in group presentation of written and oral work.
*Take part in group preparation and presentation of a plan for detailed assessment of a selected
drug and drug delivery system with special emphasis on the relevant biopharmaceurtical aspects.
*Participate in peer-review of the work of other groups
*Carry out protocols (s) of laboratory tests
*Participate satisfactorily throughout the course.
Evaluations are done by the course teachers (as "invited evaluation panel").
Aid
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment
To obtain a course certificate the students should be able to:
Knowledge
• identify and explain biopharmaceutical aspects in drug research and development (i.e. be
able to consider drugability and developability of drugs/drug delivery systems)
• refere state-of-the-art methodologies for assessment of biopharmaceutical aspects in drug
delivery
Skills
• select and use relevant scientific information in relation to planning and executing the
biopharmaceutical evaluation of a given drug/drug delivery system
• plan, prepare and present (examples of) laboratory protocols
• evaluate experimental data and relate to findings
• outline and briefly explain relevant biopharmaceutical information required to evaluate a
certain drug/drug delivery system
• outline protocol(s) for how to test some of the above in the laboratory
Workload
Category Hours
Preparation 110
Lectures 32
Class Instruction 16
Colloquia 16
Project work 32
Total 206
Course information
Language
English
Course code
TEMP141202
Credit
7,5 ECTS
Level
Part Time Master
Full Degree Master choice
Duration
1 block
Placement
Block 2
Schedule
C And C
Course capacity
60
Continuing and further education Study board
Study Board of Pharmaceutical Sciences
Contracting department
Department of Pharmacy
Course Coordinators
Hanne Mørck Nielsen (hanne.morck@sund.ku.dk)
Lecturers
Hanne Mørck Nielsen
samt op til 3 andre undervisere fra Institut for Farmaci
Saved on the 22-12-2017
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.
Accept af cookies fra ku.dk
Ku.dk bruger blandt andet cookies til at udarbejde statistik
over anvendelsen af sitet.
Du kan altid slette cookies fra ku.dk igen.
Accepter cookies Læs
mere om cookies på ku.dk
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige version.
TEMP00001 Pharmaceutical Modelling
Expand all Volume 2018/2019
Education
MSc Programme in Pharmacy and Pharmaceutical Sciences (danish programmes cand.pharm
and cand.scient.pharm) - elective
MSc Programme in Medicinal Chemistry - elective
MSc Programme in Pharmaceutical Sciences (english programme) - elective
Content
The course focuses on mathematical models for a quantitative understanding of diverse
pharmaceutically relevant problems. This includes models at different scales, both for molecular
and particle level properties, interactions between molecules/particles and their interactions with
the organism. The course will via 'real-life' practical examples provide the students with
knowledge about the theory behind methods used for pharmaceutical modelling and simulation
of system behavior. The students will be provided with input data for the different systems
studied.
In the lectures, the students are introduced to the fundamental principles behind methods in
pharmaceutical modelling. In the exercises, the students get hands-on experience with methods
used in academia and industry and get an opportunity to apply these methods on 'real-life'
problems.
The course begins with a introduction and brush-up on fundamental mathematical tools, building
on the knowledge obtained during the bachelor courses, e.g. physical chemistry. We then apply
and modify computer scripts that model the pharmaceutical systems, and discuss these models
in relation to the literature.
The topics covered in the lectures and exercises are:
• Introduction to basic multivariate calculus and linear algebra
• Introduction to differential equations
• Model optimization
• Multivariate data analysis
• Molecular dynamics
• Image analysis
Visualization of data is an important aspect of the course.
Examples on areas covered in the lectures and exercises are:
• Interatomic forces in biological and crystalline drug systems – molecular dynamics
• Image analysis of digital images from e.g. electron microscopy studies.
• Model optimization against experimental powder diffraction data
• Multivariate methods for process analytical technology, e.g. powder diffraction, Raman and
NIR spectroscopies
Objective
The course is relevant for pharmaceutical research within both drug discovery and drug
development where it is important to:
• Understand the theory behind models on various levels of the drug discovery and
development process
• Get hands-on experience with modern tools in pharmaceutical modelling
• Know the accuracy and applicability of mathematical models
Learning Outcome
At the end of the course, students are expected to be able to:
Knowledge
• Explain the mathematical principles behind selected methods used
• Be critical to the quality of the data and developed mathematical models
• To link modeling results and experimental work
Skills
• Develop pharmaceutical models
• Evaluate the accuracy of the models
• Have hands-on experience with mathematical and statistical software
Competences
• Apply models in pharmaceutical research and development
• Critically evaluate the usability of diverse computational platforms for pharmaceutical
problems
• Select the appropriate mathematical model to solve problems in pharmaceutical sciences
No prior computer programming knowledge is needed.
Literature
Literature
Munk and Munro: Maths for chemistry. Latest edition.
Lecture notes.
Software
The students will use various types of software, primarily software used in previous courses,
open source software and software used in industry.
Formal requirements
Non.
Recommended Academic Qualifications
Teaching is organized on the assumption that students already have acquired knowledge
comparable to the math curriculum on the bachelor level of the pharmacy education. No special
skills for computer programming are needed.
Teaching and learning methods
Lectures: 12 hours
Class room exercises: 10 hours
Computer exercises: 20 hours
Project work: 70 hours
Supervision during project work: Guidelines will be available on the course homepage
Mathematical test and oral presentation of group work.
Feedback form
Oral
Individual
Continuous feedback during the course of the semester
Feedback by final exam (In addition to the grade)
Sign up
Self Service at KUnet
Open for credit transfer students and other external students. Apply here:
Credit transfer students:
http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/
Other external students:
http://healthsciences.ku.dk/education/exchange_guest_students/guest-students/
Exam 1 (Continuous assessment)
Credit
2,5 ECTS
Type of assessment
Course participation
Continuous assessment
In order to obtain the course certificate the students should:
*Participate satisfactorily throughout the course.
*Complete a mathematical test on the entire curriculum to satisfaction.
*In groups prepare a written work (powerpoint or poster) within one of the four main subjects of
the course.
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment
To obtain a course certificate the student must be able to:
Knowledge
• Explain the mathematical principles behind selected methods used
• Be critical to the quality of the data and developed mathematical models
• Link modeling results and experimental work
Skills
• Develop pharmaceutical models
• Evaluate the accuracy of the models
• Have hands-on experience with mathematical and statistical software
Competences
• Apply models in pharmaceutical research and development
• Critically evaluate the usability of diverse computational platforms for pharmaceutical
problems
• Select the appropriate mathematical model to solve problems in pharmaceutical sciences
Exam 2 (Oral examination)
Credit
5 ECTS
Type of assessment
Oral examination, 30 minutes
The oral examination is individual and without preparation.
The oral examination is based on the written group work, that the student has prepared during
the course of teaching.
Aid
Without aids
It is permitted to bring the written work on which the oral examination is based on to the
examination.
Marking scale
7- point grading scale
Censorship form
No external censorship
Criteria for exam assesment
To achieve the grade 12 the student must be able to:
Knowledge
• Explain the mathematical principles behind selected methods used
• Be critical to the quality of the data and developed mathematical models
• Link modeling results and experimental work
Skills
• Develop pharmaceutical models
• Evaluate the accuracy of the models
• Have hands-on experience with mathematical and statistical software
Competences
• Apply models in pharmaceutical research and development
• Critically evaluate the usability of diverse computational platforms for pharmaceutical
problems
• Select the appropriate mathematical model to solve problems in pharmaceutical sciences
Workload
Category Hours
Lectures 12
Theory exercises 28
Preparation 70
Project work 70
Exam 20
Guidance 6
Total 206
Course information
Language
English
Course code
TEMP00001
Credit
See exam description
Level
Full Degree Master
Full Degree Master choice
Duration
1 block
Placement
Block 1
Schedule
A
Course capacity
54
Continuing and further education
Study board
Study Board of Pharmaceutical Sciences
Contracting department
Department of Pharmacy
Course Coordinators
Anders Østergaard Madsen (a.madsen@sund.ku.dk)
Lecturers
Anders Østergaard Madsen
Johan Peter Bøtker
Saved on the 19-12-2017
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.
Accept af cookies fra ku.dk
Ku.dk bruger blandt andet cookies til at udarbejde statistik
over anvendelsen af sitet.
Du kan altid slette cookies fra ku.dk igen.
Accepter cookies Læs
mere om cookies på ku.dk
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige
version.
SFAKB0021U Pharmaceutical Policy Fold alle ud
Årgang 2018/2019
Engelsk titel
Pharmaceutical Policy
Uddannelse
MSc programme in Pharmacy or Pharmaceutical Sciences - compulsory
MSc programme in Pharmaceutical Sciences (english programme) -
elective MSc programme in Medicinal Chemistry - elective
Kursusindhold
The course focuses on the areas of pharmaceutical policy making, regulatory science,
health economics evaluation and health care ethics.
Students work with real world cases applying concepts, theories and tools from various scientific
disciplines to analyze the case.
The main topics of the course are: health care systems, key actors in pharmaceutical policy
making, drug regulatory systems, systems to support rational use of medicines, core ethical
concepts used in health care, ethical aspects of pharmaceuticals and medical devices in
society, economic tools to manage medicines use and costs, prioritization in health care
systems, and health economic evaluation.
Målbeskrivelser
The aim of the course is to facilitate the students’ understanding of pharmaceutical policy
questions on the societal level based on cross-disciplinary, critical and analytical work with real
world cases.
The course should make the student able to argue on real world issues and to analyze underlying
interests, ethical and political standpoints of key actors within the pharmaceutical and medical
device arena. In addition the course should give the student basic knowledge of how health
economics is used in the pharmaceutical policy arena.
Upon completion of the course the student should be able to:
Knowledge
• Classify and describe the general traits of health care systems
• Describe the overall regulatory aspects in the field of pharmaceuticals and medical devices
• Outline regulation, funding, pricing and distribution of medicines in society
• Describe basic concepts in health economics and priority setting in health care
• Describe basic concepts in health care ethics
Skills
• Identify the different actors' interests and how they argue their positions
• Apply concepts to identify political, ethical and health economic aspects of pharmaceutical
policy
• Identify ethical issues in the field of pharmaceuticals and medical devices
• Conduct well-founded ethical argumentation regarding pharmaceutical issues using basic
ethics concepts
• Identify and discuss the relevance of a given health economic evaluation and the outcome
measures used
• Evaluate and discuss the choices made in health economic evaluations
Competencies
• Discuss and synthesize current issues in the field of pharmaceuticals and medical devices
overall, based on both political, economic and ethical/ ideological aspects using relevant
tools and concepts
• Be able to critically evaluate and extract well-balanced conclusions from published health
economic evaluations.
Undervisningsmateriale
Book to be decided.
Scientific literature, media debates, articles, links to homepages, etc. posted on Absalon
Formelle krav
Non.
Anbefalede faglige forudsætninger
The course assumes skills commensurate to a Bachelor in Pharmacy including a course in Social
Pharmacy or equivalent insight into the user perspective on medicines and basic knowledge of
drug utilization statistics.
Undervisningsform
• Lectures and discussion seminars
• Case work in groups and discussion of cases
Feedbackform
Kollektiv
Peerfeedback (studerende giver hinanden feedback)
Tilmelding
Selvbetjeningen på KUnet
Open for credit transfer students and other external students. Apply
here: Credit transfer students:
http://sund.ku.dk/uddannelse/vejledning-information/meritstuderende/
Other external students:
http://sund.ku.dk/uddannelse/efter-og-videreuddannelser/enkeltfag/
Credit transfer and other external students are welcome on the course if there are
available seats and they have the academic qualifications.
Eksamen (SFAKB0021E - skriftlig prøve)
Point
7,5 ECTS
Prøveform
Skriftlig prøve, 6 timer med opsyn.
Written exam, 6 hours of supervision. The exam consists of questions for one or more cases
focusing on the subject areas of policy, ethics and economics. The documents related to the
cases are handed out 24 hours prior to the actual examination via Absalon, while the specific
form of the questions is handed out in the written exam.
Hjælpemidler
Skriftlige hjælpemidler tilladt
There is access to the following, at the exam on Peter Bangs Vej:
• Officepakken (Word, Excel, Onenote og Powerpoint)
• IO2 – the digital pen
• Panoramic Viewer
• Paint
• Calculator – Windows´own
• R – Statistical programme
• ITX MC – multiple choice programme
• Adobe reader
• MathType - formular programme
• Mable
• USB access – for usb stick with notes ect.
Bedømmelsesform
7- trins skala
Censurform
Ekstern censur
Kriterier for bedømmelse
To pass the exam the student must be able
to: Knowledge
• Classify and describe the general traits of health systems
• Describe the overall regulatory aspects in the field of pharmaceuticals and medical devices
• Outline regulation, funding, pricing and distribution of medicines in society
• Basic concepts in health economics and priority setting in health care
• Basic concepts in health care ethics
Skills
• Identify the different actors' interests and how they argue their positions
• Apply concepts to identify political, ethical and health economic aspects of pharmaceutical
policy
• Identify ethical issues in the field of pharmaceuticals and medical devices
• Conduct well-founded ethical argumentation regarding pharmaceutical issues using basic
ethics concepts
• Identify and discuss the relevance of a given health economic evaluation and the outcome
measures used
• Evaluate and discuss the choices made in health economic evaluations
Competencies
• Be able to discuss and synthesize current issues in the field of pharmaceuticals and
medical devices using relevant tools and concepts
• Be able to critically evaluate and extract well-balanced conclusions from published
health economic evaluations.
Arbejdsbelastning
Kategori Timer
Forelæsninger 34
Seminar 16
Øvelser 12
Forberedelse 106
Eksamen 38
I alt 206
Kursusinformation
Sprog
Engelsk
Kursuskode
SFAKB0021U
Point
7,5 ECTS
Niveau
Kandidat
Varighed
1 blok
Placering
Blok 1
Skemagruppe
A (tirs 8-12 + tors 8-17)
Kursuskapacitet
180 students (reserved students at master programmes in Pharmacy or Pharmaceutical
Sciences).
Efter- og videreuddannelse Studienævn
Studienævn for de Farmaceutiske Videnskaber
Udbydende institut
Institut for Farmaci
Kursusansvarlige
Anna Birna Almarsdóttir (aba@sund.ku.dk)
Social and Clinical Pharmacy
Study secretary: Malthe Sørensen (studieservice-UP2@sund.ku.dk)
Gemt den 03-01-2018
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige version.
TEMP181901 Pharmacoepidemiology and
Pharmacovigilance
Expand all Volume 2018/2019
Education
MSc Programme in Pharmacy or Pharmaceutical Science (danish programmes Cand.Pharm and
Cand.Scient.Pharm) - elective
MSc Programme in Pharmaceutical Sciences (english programme) - elective
Content
The principles of pharmacoepidemiology and pharmacovigilance are presented, including the
related processes in the pharmaceutical industry and regulatory authorities. Lectures are
supplemented with group discussions and exercises with calculations in a spreadsheet or
statistical software. During the last weeks of the course, the students will in groups prepare a
project report based on a case scenario where they develop and write up either an
epidemiological study protocol, a risk management plan or a risk/benefit assessment. The written
report is evaluated, presented orally and critically assessed by the other groups. Topics are:
• Introduction to pharmacovigilance
◦ Definitions, background and history
◦ Institutions and individuals involved in pharmacovigilance
◦ Sources of information on drug-related risks
• Pharmacoepidemiological methods
◦ Measures of occurrence and effect
◦ Cohort and case-control study designs
◦ Sources of error, bias and confounding
◦ Data sources, validity and limitations
◦ Analysis of epidemiological studies
◦ Drug utilisation studies and quality indicators of drug use
◦ Post-approval safety studies – protocols and practice
• Spontaneous reporting systems
◦ Individual case safety reports, clinical diagnosis coding and causality assessment
◦ Quantitative signal detection and signal evaluation
• Regulatory aspects of pharmacovigilance
◦ Pharmaceutical industry safety reporting and risk management plans
◦ Good pharmacovigilance practices
◦ Regulatory processes and decisions
◦ Benefit/risk assessment
Learning Outcome
The aim of the course is to give students knowledge about the principles of
pharmacoepidemiology and pharmacovigilance. Additionally, to provide students with an
understanding of the different types of evidence produced by experimental and observational
studies of drug effects, and of the strengths and weaknesses of different study designs and
methods. The students should be able to choose design and data sources that best fit the
purpose of a study, and to critically evaluate published literature on drug safety, efficacy and
effectiveness. They should be able integrate results from safety surveillance and post-approval
studies with other preclinical and clinical safety information.
After completing the course the student is expected to be able to:
Knowledge
• understand pharmacoepidemiological and pharmacovigilance methods used to generate
the evidence for benefit/risk assessments
• understand and explain central pharmacoepidemiological and pharmacovigilance
concepts.
• explain principles of safety surveillance and risk management, including the obligations of
the pharmaceutical industry and the basis for regulatory decisions.
• identify and summarise the limitations of pharmacoepidemiological studies and safety
surveillance systems.
Skills
• describe, analyse and interpret the results of pharmacoepidemiological studies and safety
surveillance.
• assess and discuss the limitations of data and methods in published literature and safety
reports.
• summarise and prioritise safety information obtained with different methods in a
structured way.
• communicate information on safety issues and drug-related risks.
Competences
• independently develop a protocol and plan for a post-authorisation safety study.
• perform a general benefit/risk assessment of a drug, integrating results from studies on
efficacy and safety, data from safety surveillance systems and other information.
• outline a risk management plan for a marketed drug based on information on safety issues
and patterns of use.
Literature
Selected textbook chapters, lecture notes, laws, documents, recommendations, circulars,
guidelines and scientific papers.
Formal requirements
Non.
Recommended Academic Qualifications
Course teaching is based on the assumption that students have knowledge corresponding to the
content of the courses Basic Pharmacology, Organ-related Pharmacology, Pharmacotherapy and
Toxicology. For MSc students Principles of Pharmacology and Pharmacology: From Physiology to
Therapy.
Teaching and learning methods
Lectures: 40 (45 min.)
Group and classroom discussions: 15 (45 min.)
Case project and report: 70
Feedback form
Oral
Continuous feedback during the course of the semester
Peer feedback (Students give each other feedback)
Sign up
Self Service at KUnet
Open for credit transfer students and other external students. Apply here:
Credit transfer students:
http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/
Other external students: http://healthsciences.ku.dk/education/exchange_guest_students/guest-
students/
Exam (continuous assessment)
Credit
7,5 ECTS
Type of assessment
Course participation
Written assignment
Course certificate: During the last weeks of the course, the students will in groups prepare a
project report based on a case scenario where they develop and write up either an
epidemiological study protocol, a risk management plan or a risk/benefit assessment. The written
report is evaluated, presented orally and critically assessed by the other groups.
The assessment will be based on the project report and satisfactory participation in the course in
general.
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment
To obtain a course certificate the student must be able to:
Knowledge
• understand pharmacoepidemiological and pharmacovigilance methods used to generate
the evidence for benefit/risk assessments
• understand and explain central pharmacoepidemiological and pharmacovigilance
concepts.
• explain principles of safety surveillance and risk management, including the obligations of
the pharmaceutical industry and the basis for regulatory decisions.
• identify and summarise the limitations of pharmacoepidemiological studies and safety
surveillance systems.
Skills
• describe, analyse and interpret the results of pharmacoepidemiological studies and safety
surveillance.
• assess and discuss the limitations of data and methods in published literature and safety
reports.
• summarise and prioritise safety information obtained with different methods in a
structured way.
• communicate information on safety issues and drug-related risks.
Competences
• independently develop a protocol and plan for a post-authorisation safety study.
• perform a general benefit/risk assessment of a drug, integrating results from studies on
efficacy and safety, data from safety surveillance systems and other information.
• outline a risk management plan for a marketed drug based on information on safety issues
and patterns of use.
Workload
Category Hours
Lectures 40
Preparation 81
Theory exercises 10
Project work 70
Class Exercises 5
Total 206
Course information
Language
English
Course code
TEMP181901
Credit
7,5 ECTS
Level
Full Degree Master
Full Degree Master choice
Duration
1 block
Placement
Block 3
Schedule
C
Course capacity
60 students
Continuing and further education Study board
Study Board of Pharmaceutical Sciences
Contracting department
Department of Drug Design and Pharmacology
Course Coordinators
Morten Andersen (morten.andersen@sund.ku.dk)
Saved on the 22-12-2017
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.
Accept af cookies fra ku.dk
Ku.dk bruger blandt andet cookies til at udarbejde statistik
over anvendelsen af sitet.
Du kan altid slette cookies fra ku.dk igen.
Accepter cookies Læs
mere om cookies på ku.dk
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige version.
TEMP1234RS Regulatory Science
Expand all Volume 2018/2019
Education
MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and
cand.scient.pharm) - elective
MSc Programme in Medicinal Chemistry - elective
MSc Programme in Pharmaceutical Sciences (English programme) - elective
Content
Pharmaceuticals are one of the most regulated products in society. The policies and regulations
influencing the availability and use of pharmaceuticals are international, national and local.
Regulators and drug developer must make decisions from the earliest preclinical stages through
all phases of drug development.
The regulatory framework for medicines is constantly evolving. The system changes in order to
adapt to scientific developments; address medical needs; bring medicines to patients earlier (and
with better evidence); and also to keep prescribing information up to date. In Regulatory Science
we seek to study and evaluate the regulatory system as such in terms of impact on ensuring
patient safety, enhancing public health and stimulating the development of medicines.
The aim of the course is to give participants insight into and understanding of Regulatory Science
as well as giving the participants a better understanding of the theories and methods available
for analysing the effects of regulatory systems and interventions.
Learning Outcome
On completion of the course participants should be able to:
Knowledge
• Understand the current regulatory system of medicines
• Understand the political and legal framework of drug regulation
• Describe the traditional process of drug discovery and development, and relate this to the
current regulatory framework
• Describe various research approaches applied in regulatory science
• Describe use of strategies and existing data sources for to be used in Regulatory Science
research
Skills
• Identify and conceptualise relevant regulatory science research question and hypothesis,
through analysing the scientific literature in context of regulatory systems
• Identify and apply approaches and methods to address Regulatory Science research
questions
• Identify appropriate data sources, and methods for data extraction and validation, to study
a regulatory science research question.
Competences
• Discuss and critique Regulatory Science research and its implications
• Effectively communicate the value of Regulatory Science, including priorities and gaps to
stakeholders, including colleagues, policy makers, the media, and the public
Literature
Background literature on applicable theory and research methods
Scientific literature
Relevant Regulatory Guidelines
Formal requirements
Non.
Recommended Academic Qualifications
A bachelor’s degree in health, natural or technical sciences.
Teaching and learning methods
Lectures and teaching in classes (50 hours in total).
Group case work including preparation of written reports and oral presentations as well as
smaller individual assignments (100 hours)
Preparation for classes, self-study (56 hours).
Feedback form
Continuous feedback during the course of the semester
Feedback by final exam (In addition to the grade)
Peer feedback (Students give each other feedback)
Sign up
Self Service at KUnet
This course is not available for credit transfer students and other external students.
Exam (Continuous assessment)
Credit
7,5 ECTS
Type of assessment
Oral defence
In order to obtain the course certificate the students should:
Participate to a satisfactory level
Submit written work
Take part in group presentation of written work.
Present individual written review
Be able to discuss and critique own and others work
Aid
Written aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment
To obtain a course certificate the student should be able to:
Knowledge
• Understand the current regulatory system of medicines
• Understand the political and legal framework of drug regulation
• Describe the traditional process of drug discovery and development, and relate this to the
current regulatory framework
• Describe various research approaches applied in regulatory science
• Describe use of strategies and existing data sources for to be used in Regulatory Science
research
Skills
• Identify and conceptualise relevant regulatory science research question and hypothesis,
through analysing the scientific literature in context of regulatory systems
• Identify and apply approaches and methods to address Regulatory Science research
questions
• Identify appropriate data sources, and methods for data extraction and validation, to study
a regulatory science research question.
Competences
• Discuss and critique Regulatory Science research and its implications
• Effectively communicate the value of Regulatory Science, including priorities and gaps to
stakeholders, including colleagues, policy makers, the media, and the public
Workload
Category Hours
Lectures 50
Course Preparation 56
Study Groups 100
Total 206
Course information
Language
English
Course code
TEMP1234RS
Credit
7,5 ECTS
Level
Full Degree Master
Full Degree Master choice
Duration
1 block
Placement
Block 4
Schedule
C
Course capacity
60
Study board
Study Board of Pharmaceutical Sciences
Contracting department
Department of Pharmacy
Course Coordinators
Christine Erikstrup Hallgreen (christine.hallgreen@sund.ku.dk)
Lecturers
Christine Erikstrup Hallgreen (zkj621)
Marie Louise De Bruin
External lectures Saved on the 22-12-2017
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige version.
SFKKB9091U In-vitro Techniques in Biochemistry and
Pharmacology
Expand all Volume 2018/2019
Education
MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and
cand.scient.pharm) - elective
MSc Programme in Medicinal Chemistry - elective
MSc Programme in Pharmaceutical Sciences (English programme)- elective
MSc Programme in Environmental Science (SCIENCE) - restricted elective
Content
The following practical elements are included: primary cell cultures, neurotransmitter
transporters, receptor activation (GPRC and ligand-gated ion-channel receptors), receptor
binding, TEVC electrophysiology, voltage-clamp fluorometry (VCF), second messenger
measurements, FRET, smooth muscle contraction/relaxation, CytP450 and drug metabolism,
separation of lipophilic drug metabolites, use of radioisotopes, drug effects on isolated
mitochondria.
Learning Outcome
By the end of the course, the students will have acquired the competences to:
Knowledge
• demonstrate a firm knowledge of in vitro pharmacology
• understand common in vitro experimental methodologies as applied in pharmacology
• demonstrate a basic knowledge of pharmacodynamic theory
• demonstrate a basic understanding of radioisotope theory in scintillation counting
Skills
• The students will acquire practical and theoretical abilities and skills in pharmacological in
vitro research techniques that are applicable in both academic and biotech/pharmaceutical
drug discovery research environments. The specific aim is to acquire the abilities and
practical skills required to be able to work in a pre-clinical drug discovery research
environment and/or communicate proficiently with other professionals.
• prepare cultures of primary mouse neurons
• execute neurotransmitter uptake experiments employing cultured neurons
• measure cAMP (second-messenger) in cultured cells by FRET
• employ isolated mouse vas deferens to measure the effect of morphine-like pain-relieving
drugs
• employ two-electrode voltage clamp (TEVC) electrophysiology technique as a functional
assay of drugs affecting the operation of ion channels
• employ voltage clamp fluorometry (VCF) technique as a functional assay of drugs affecting
the operation of ion channels
• employ radioligand binding assays in drug investigations and interpret the resulting
pharmacologial data
• analyze cytochrome P450-mediated metabolism of a radiolabeled drug in a liver
homogenate employing thin layer chromatography (TLC) and subsequent scintillation
counting
• isolate crude mitochondria from a mouse liver homogenate
• employ isolated mitochondria to perform a simple in vitro screen of toxicity related to
mitochondrial function of unknown drugs.
Competences
• work with and/or communicate proficiently with other professionals within the field of in
vitro pharmacology
• design simple in vitro assays of drug activity including choosing the proper model system
and assay conditions
• calculate and interpret pharmacological data (dose-response relationships)
• apply knowledge of in vitro pharmacology to evaluate pharmacological data in relation to
the drug discovery process
Literature
• Lab manual (Pickering and Hansen)
• Receptor theory notes (Sheykhzade and Pickering)
• Radioisotope theory notes (Hansen and Pickering)
Recommended Academic Qualifications
Students should have completed bachelor’s level lecture course(s) in biochemistry and/or
pharmacology as well as a lab course in chemistry and/or biochemistry.
Teaching and learning methods
Lab exercises: 40 hours
Tutorials: 21 hours
Remarks
The schedule for this course is not compatible with that of Clinical Pharmacy Practice
(SFKKB9011U).
This course also runs in week 42.
Attendance in all lab exercises and tutorials is mandatory.
Feedback form
Oral
Collective
Continuous feedback during the course of the semester
Sign up
Self Service at KUnet
Open for credit transfer students and other external students. Apply here:
Credit transfer students:
http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/
Other external students:
http://healthsciences.ku.dk/education/exchange_guest_students/guest-students/
Credit transfer and other external students are welcomed on the course if there are seats
available and they have the academic qualifications.
Exam (SFKKB9091E - written examination)
Credit
7,5 ECTS
Type of assessment
Written examination, 2 hours under invigilation
Examination design
The course examination will consist of 20 short-answer questions covering the practical and
theoretical aspects of all the laboratory exercises. All written answers will be given an equal
weighting and then the course leaders will assess the overall examination performance level.
Students must have attended all the laboratory exercises and tutorials.
Aid
Without aids
There is access to the following at the exam on Peter Bangs Vej:
• Office (Word, Excel, Onenote and Powerpoint)
• IO2 – the digital pen
• Panoramic Viewer
• Paint
• Calculator – Windows' own
• R – Statistical programme
• MathType formel programme
• Maple
• ITX MC – multiple choice programme
• Adobe reader usb is not allowed
Marking scale
7- point grading scale
Censorship form
No external censorship
Criteria for exam assesment
To achieve the grade 12 the student must be able to:
Knowledge
• demonstrate a firm knowledge of in vitro pharmacology
• understand common in vitro experimental methodologies as applied in pharmacology
• demonstrate a basic knowledge of pharmacodynamic theory
• demonstrate a basic understanding of radioisotope theory in scintillation counting
Skills
• prepare cultures of primary mouse neurons
• execute neurotransmitter uptake experiments employing cultured neurons
• measure cAMP (second-messenger) in cultured cells by FRET
• employ isolated mouse vas deferens to measure the effect of morphine-like pain-relieving
drugs
• employ two-electrode voltage clamp (TEVC) electrophysiology and voltage-clamp
fluorometry (VCF) techniques as a functional assay of drugs affecting the operation of ion
channels
• employ radioligand binding assays in drug investigations and interpret the resulting
pharmacologial data
• analyze cytochrome P450-mediated metabolism of a radiolabeled drug in a liver
homogenate employing thin layer chromatography (TLC) and subsequent scintillation
counting
• isolate crude mitochondria from a mouse liver homogenate
• employ isolated mitochondria to perform a simple in vitro screen of toxicity related to
mitochondrial function of unknown drugs.
Competences
• work with and/or communicate proficiently with other professionals within the field of in
vitro pharmacology
• design simple in vitro assays of drug activity including choosing the proper model system
and assay conditions
• calculate and interpret pharmacological data (dose-response relationships)
• apply knowledge of in vitro pharmacology to evaluate pharmacological data in relation to
the drug discovery process
Workload
Category Hours
Colloquia 21
Lectures 1
Preparation 80
Exam Preparation 64
Practical exercises 40
Total 206
Course information
Language
English
Course code
SFKKB9091U
Credit
7,5 ECTS
Level
Full Degree Master
Duration
1 block
Placement
Block 1
Schedule
C
Course capacity
56 students
Continuing and further education
Study board
Study Board of Pharmaceutical Sciences
Contracting department
Department of Drug Design and Pharmacology
Course Coordinators
Darryl S Pickering (picker@sund.ku.dk)
Study secretary: Malthe Sørensen (studieservice-UP2@sund.ku.dk)
Lecturers
Announced at the course start.
Saved on the 22-12-2017
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige version.
SFKKIF007U Advanced Manufacturing of
Pharmaceuticals
Expand allVolume 2018/2019
Education
MSc Programme in Food Science and Technology with specialization
in Process Analytical Technology (SCIENCE) - compulsory
MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and
cand.scient.pharm) - elective
MSc Programme in Medicinal Chemistry - elective
MSc Programme in Pharmaceutical Sciences (English programme) - elective
Content
The course will introduce the critical tools needed for future professionals working in drug
development and manufacturing of pharmaceuticals. The main goal is to provide students with
knowledge required for designing robust medicinal product using Quality by Design (QbD)
principles. The course will start by introducing the unit operations used in manufacturing of
pharmaceuticals. This part covers primary manufacturing of both small molecules (synthesis and
crystallization) as well as biologics (fermentation and related separation technologies), followed
by introduction of secondary manufacturing steps (granulation, tableting and coating), as well as
spray/freeze drying technologies for biologics. Special focus will be on introducing enabling
manufacturing solutions for nanomedicine. Theory and practice will be introduced hand in hand
with lectures and excursions to local industry including examples from both small molecule and
biologics. Next phase involves the introduction of central Quality by Design tools - Design of
Experiments (DoE) and chemometrics, as well as physical modelling of system behavior. Students
will be introduced to different levels of modelling used in designing robust manufacturing
processes – starting from modelling molecular interactions explaining the behaviour of systems
with pharmaceutical interest, and proceeding to modelling of process performance based on
engineering principles. Specific examples of process analytical technologies (PAT) will be
discussed with a special focus on analytical tools applicable for the analysis of moving matter.
The last part of the course provides deeper insight into the general structure of pharmaceutical
quality systems and risk management approaches. Principles of the plant design of
pharmaceutical manufacturing sites will be introduced. For project work, students will work in
small groups of 4 students around given formulation/processing example. Project work will be
presented during project presentation.
Learning Outcome
To provide students with fundamental knowledge related to manufacturing of pharmaceuticals.
Participants will gain deeper insight into all critical unit operations of pharmaceutical interest, as
well as an introduction to functions of pharmaceutical quality systems and plant design
principles. All this will be introduced as a sound combination of lectures and excursions to local
industry. The Quality by Design (QbD) approach will be a key element in the course. Design of
Experiments (DoE) and chemometrics, as well as physical modelling will be explained through
lectures and practical exercises. After finishing the course, students should also be able to use
the physicochemical principles to analyse the processability of a given dosage form.
At the end of the course, students are expected to be able to:
Knowledge
• analyse the critical unit operations used in manufacturing of small molecule and biologics
based medicinal products
• understand the importance of formulation design in relation to manufacturing according to
Quality by Design (QbD) principles
• demonstrate insight into pharmaceutical quality systems, risk management techniques and
plant design of pharmaceutical manufacturing sites
Skills
• perform Design of Experiments (DoE) and multivariate data analysis
• construct risk assessment of a given pharmaceutical product
• apply the general principles of physical modelling related to manufacturing of
pharmaceuticals.
Literature
Lecture notes and relevant publications are available from the course homepage.
Formal requirements
Non.
Recommended Academic Qualifications
Students are expected to have a good knowledge of formulation and processing of dosage forms,
as well as an interest in becoming a future specialist in the field of pharmaceutical development.
Teaching and learning methods
Theory and practice will be introduced hand in hand with lectures and excursions to local
industry including examples from both small molecule and biologics. For project work, students
will work in small groups of 4 students around given formulation/processing example. Project
work will be presented during project presentation.
•Lectures: 32 hours
•Demonstration: 4 hours
•Excursions: 12 hours
•Seminar: 4 hours
Sign up
Self Service at KUnet
Open for credit transfer students and other external students. Apply here:
Credit transfer students:
http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/
Other external students:
http://healthsciences.ku.dk/education/exchange_guest_students/guest-students/
Credit transfer and other external students are welcomed on the course if there are seats
available and they have the academic qualifications.
Exam (SFKKIF007U - continuous assessment)
Credit
7,5 ECTS
Type of assessment
Course participation
Course certificate:
The student will achieve a course certificate when participation satisfactory during the lectures,
exercises, project work and project presentation.
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment
Satisfactory participation during the lectures, exercises, project work and project presentation.
To pass the course the student must be able to:
Knowledge
• analyse the critical unit operations used in manufacturing of small molecule and biologics
based medicinal products
• understand the importance of formulation design in relation to manufacturing according to
Quality by Design (QbD) principles
• demonstrate insight into pharmaceutical quality systems, risk management techniques and
plant design of pharmaceutical manufacturing sites
Skills
• perform Design of Experiments (DoE) and multivariate data analysis
• construct risk assessment of a given pharmaceutical product
• apply the general principles of physical modelling related to manufacturing of
pharmaceuticals.
Workload
Category Hours
Lectures 32
Project work 76
Practical exercises 4
Excursions 12
Colloquia 4
Preparation 78
Total 206
Course information
Language
English
Course code
SFKKIF007U
Credit
7,5 ECTS
Level
Full Degree Master
Duration
1 block
Placement
Block 2
Schedule
B
Course capacity
60 students
Continuing and further education
Study board
Study Board of Pharmaceutical Sciences
Contracting department
Department of Pharmacy
Course Coordinators
Jukka Rantanen (jukka.rantanen@sund.ku.dk)
Study secretary: Malthe Sørensen (studieservice-UP2@sund.ku.dk)
Saved on the 22-12-2017
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige version.
SLKKIL110U Advances in Medicinal Chemistry
Research
Expand all Volume 2018/2019
Education
MSc Programme in Pharmaceutical Sciences (English programme) track I - compulsory
MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and
cand.scient.pharm) - elective
MSc Programme in Medicinal Chemistry - elective
Content
The course will be based on 3-4 major themes covering the objectives of the course. Hence, all
subjects will be introduced in a theme driven interdisciplinary fashion. The themes will be
illustrated by original scientific reports and may cover:
• Target classes: receptors, transporters, enzymes, regulatory proteins
• Target-ligand interactions
• Structure – activity relationship (SAR) studies
• Structure and ligand based drug design
• Point of action and the prodrug concept
• Peptidomimetics and protein based drugs
• Drugability of lead compounds
• Experimental methods in biological and biostructural chemistry
• Basic and advanced medicinal chemistry concepts
• 3D modeling of protein structure and ligand docking
As the course aims to highlight recent cutting edge research in medicinal/biostructural chemistry,
themes vary but may cover: hypnotics, psychotropic drugs, immunomodulating agents, antiviral
agents, neurotransmitters, chemotherapeutics, antineoplastics, drugs against neurodegenerative
diseases and schizophrenia. During the course the students will cover three themes in groups of
4-5 persons. for each theme the groups will carry out literature search, write up a report and
prepare a poster for oral presentation.
Learning Outcome
The original literature plays a pivotal role in the discovery of new drugs. In order to contribute to
the process it is necessary to comprehend and to be able to communicate the content of primary
research papers to others. The literature is the primary source of information in all steps of the
drug discovery process including:
• Biology of targets
• Identification of interfering agents (drug candidates).
• Optimization of interfering agents.
Importantly, the course aims at providing knowledge about the above-mentioned individual
steps, while ensuring that the students do not consider each process isolated from the others.
Hence, the students will have a collected understanding of biostructural/medicinal chemical
aspects. Earlier courses provide in-depth insight to isolated techniques/theory. Rather, at this
later time-point in the student’s education, an integrated view is acquired.
Drugs interfere with complex biological systems. In order to design targeted and specific drugs it
is necessary to understand the system they interact with. Researchers will need to be able to
quickly understand new techniques for the identification and optimization of biologics and small
molecule compounds. The course objective is to train the students in acquiring the above-
mentioned skills. They will work with original literature concerning particular indications. The
indications may vary, and can include: cancer, diseases of the central nervous system, viral
infections, neurodegenerative diseases, amyloid diseases.
At the end of the course, students will be able to:
Knowledge
• understand that particular cellular processes at the molecular level may lead to disease
• understand the content of original literature describing complex biological systems of
relevance in drug research
• understand how the 3-dimensional structure of biological macromolecules plays a role for
understanding the molecular basis of particular diseases, and for intervening with the
disease progress
• understand the content of original literature describing the identification and optimization
of small molecule compounds that can interfere with complex biological systems
• understand the content of original literature describing the impact of interfering with
protein-protein interactions using designed biological macromolecules (biologics)
• understand how medicinal chemistry is an interdisciplinary field, building on basic scientific
understanding of molecular and biological processes, exploiting detailed structural
information and applying advanced chemistry for purposeful intervention
Skills
• choose experimental techniques and methods for use in the different stages in medicinal
chemistry research
• compare and assess results obtained using different techniques and methods in medicinal
chemistry research
• critically assess potentially conflicting reports in original literature
• select essential literature for a specific topic
• compare and assess the quality of 3D structural knowledge based on either experimental
data or homology models
Competences
• collaborate and coordinate projects together with other professionals with expertise in
medicinal chemistry related areas
• extract relevant and detailed information concerning a particular drug target from 3-D
structural data files
• disseminate knowledge from the literature in a comparative and critical fashion
• translate relevant information from the basic understanding of the cellular biology behind
diseases, via a molecular understanding of the relevant targets, to the relevance of
chemical optimization of lead molecules for intervention.
Literature
Reviews and original scientific papers available at the course website.
Formal requirements
Non.
Recommended Academic Qualifications
The teaching is arranged with the assumption that students have knowledge from basic courses
in organic chemistry, physical chemistry, biochemistry, general pharmacology and medicinal
chemistry.
Teaching and learning methods
•Lectures: 9
•Class lessons: 17
Feedback form
Written
Oral
Individual
Collective
Sign up
Self Service at KUnet
Open for credit transfer students and other external students. Apply here:
Credit transfer students:
http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/
Other external students:
http://healthsciences.ku.dk/education/exchange_guest_students/guest-students/
Credit transfer and other external students are welcomed on the course if there are seats
available and they have the academic qualifications.
Exam (SLKKIL110E - oral examination)
Credit
7,5 ECTS
Type of assessment
Oral examination, 25 min
The oral examination consists of a 20 min. student presentation and questioning by examiner
followed by 5 min. evaluation. The exam is without preparation time.
Examination is based on a poster presentation, submitted by the student.
Aid
Without aids
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment
To achieve the grade Passed, the student must adequately be able to:
Knowledge
• understand that particular cellular processes at the molecular level may lead to disease
• understand the content of original literature describing complex biological systems of
relevance in drug research
• understand how the 3-dimensional structure of biological macromolecules plays a role for
understanding the molecular basis of particular diseases, and for intervening with the
disease progress
• understand the content of original literature describing the identification and optimization
of small molecule compounds that can interfere with complex biological systems
• understand the content of original literature describing the impact of interfering with
protein-protein interactions using designed biological macromolecules (biologics)
• understand how medicinal chemistry is an interdisciplinary field, building on basic scientific
understanding of molecular and biological processes, exploiting detailed structural
information and applying advanced chemistry for purposeful intervention
Skills
• submit three written reports to a satisfactory level
• participate in oral presentations of the subjects, that are based on poster presentations.
• choose experimental techniques and methods for use in the different stages in medicinal
chemistry research
• compare and assess results obtained using different techniques and methods in medicinal
chemistry research
• critically assess potentially conflicting reports in original literature
• select essential literature for a specific topic
• compare and assess the quality of 3D structural knowledge based on either experimental
data or homology models
Competences
• collaborate and coordinate projects together with other professionals with expertise in
medicinal chemistry related areas
• extract relevant and detailed information concerning a particular drug target from 3-D
structural data files
• disseminate knowledge from the literature in a comparative and critical fashion
• translate relevant information from the basic understanding of the cellular biology behind
diseases, via a molecular understanding of the relevant targets, to the relevance of
chemical optimization of lead molecules for intervention.
Workload
Category Hours
Lectures 26
Project work 88
Preparation 91,5
Exam 0,5
Total 206,0
Course information
Language
English
Course code
SLKKIL110U
Credit
7,5 ECTS
Level
Full Degree Master
Duration
1 block
Placement
Block 4
Schedule
A
Course capacity
30 students (20 seats reserved to students at the MSc Programme in Pharmaceutical Sciences).
Continuing and further education Study board
Study Board of Pharmaceutical Sciences
Contracting department
Department of Drug Design and Pharmacology
Course Coordinators
Bente Frølund (bfr@sund.ku.dk)
Study secretary: Jeanette Bangsbøll Dunn (studieservice-UP2@sund.ku.dk)
Saved on the 24-11-2017
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.
Accept af cookies fra ku.dk
Ku.dk bruger blandt andet cookies til at udarbejde statistik
over anvendelsen af sitet.
Du kan altid slette cookies fra ku.dk igen.
Accepter cookies Læs
mere om cookies på ku.dk
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige version.
SFKKIF002U Biopharmaceuticals: Protein Production and
Analysis - Is scheduled for autumn 2019
Expand all Volume 2018/2019
Education
MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and
cand.scient.pharm) - elective
MSc Programme in Medicinal Chemistry - elective
MSc Programme in Pharmaceutical Sciences (English programme) - elective
Content
This course aims to provide students with the required practical laboratory competencies for
preparatory and analytical research with proteins during pharmaceutical development. During
the course the students will gain competency with the key in-vitro techniques for working with
proteins in a laboratory. Specifically, the course covers recombinant protein expression, protein
purification and analysis of proteins and in particularly how these aspects are closely
interconnected for quality control/analysis of protein biopharmaceuticals in the phamacopoiea.
Topics will be dealt with from a practical perspective relevant to both academic and
biotech/pharmaceutical drug discovery/development environments.
The most relevant course topics are:
• Physicochemical properties of peptides and proteins and challenges to in-vitro handling
and laboratory work with proteins (protein stability, pH, temperature, concentration,
aggregation, unfolding)
• Introduction to protein sequence databases (Uniprot, Protein Data Bank)
• Recombinant protein expression in host cells (E.coli, yeast, mammalian cells)
• Principles of protein separation and chromatographic purification (affinity, ion-exchange,
size-exclusion, HIC, HPLC)
• Basic methods for analysis of primary protein structure (SDS-PAGE, intact mass analysis by
mass spectrometry (MS))
• Advanced methods for analysis of primary structure and covalent modifications (amino
acid analysis, LC-MS, IEF, peptide mapping analysis by enzymatic digestion and MS)
• Methods for analysis of the higher-order structure of protein biopharmaceuticals during
development (fluorescence, CD, NMR, SEC, DLS, HDX-MS etc.)
• Quality control of protein biopharmaceuticals in the pharmacopoiea
• Methods for quantitation of proteins in pure samples (spectroscopy, biochemical assays)
and in complex biological samples (host cell protein analysis, pharmacokinetics, drug
metabolism
This course is centered around a practical component that involves a series of open structured
laboratory sessions where students in groups are provided an unknown protein sample and
access to lab stations with equipment for purifying and analyzing proteins. The laboratory work
in this course should therefore be viewed as a mini-research project rather than a predefined
series of laboratory exercises. By applying theory learned during the lectures, the students will
plan their experimental work in an independent manner and subsequently carryout the
purifcation and analysis/quality control of a protein of interest in the unknown sample.
As part of this laboratory-based course, the students will write a group report that describes a
detailed description and interpretation of results obtained during their laboratory project.
Furthermore, each student must prepare an appendix to the group report on a individually
chosen study topic of interest in preparatory or analytical biopharmaceutical science.
Finally, students of the course will get the opportunity to participate in a one-day excursion to
Novo Nordisk A/S where two in-house scientists will give lectures on how protein production and
analysis is performed at a large biopharmaceutical company like Novo Nordisk. This excursion
will also include a tour of facilities at Novo Nordisk for large scale protein expression and
purification.
Learning Outcome
The objective of this course is to provide the students with the knowledge and practical
competencies neccesary for experimental work with proteins in a laboratory setting. The specific
aim is for students to acquire abilities and skills with the handling, purification and analysis of
proteins and/or be able to communicate proficiently with researchers in a biotech drug
discovery/development environment.
At the end of the course, students are expected to be able to:
Knowledge
• describe the primary structure, covalent modifications and higher-order structure of
proteins and how these determine protein function.
• understand the basic chemical and physical properties of proteins in solution (charge,
solubility, hydrophobicity, affinity).
• explain the principles of recombinant protein expression and the strengths/weaknesses of
different host cell systems.
• describe the common methods for protein purification and their underlying physical
principles for protein separation
• understand the common methods for analysis of protein primary structure and common
covalent modifications of proteins
• understand the common methods for analysis of higher order protein structure and
physical size/oligomerization.
• understand methods for quality control of protein biopharmaceuticals in the
pharmacopoiea.
• search bioinformatics databases for the aminoacid sequence, molecular mass and
chemical properties of a target protein
• search bioinformatics databases for structural information for a target protein and visaluze
higher-order protein structure using molecular graphics software.
Skills
• identify the strengths and weaknesses of different analytical methods to analyze the
primary or higher-order structure of protein biopharmaceuticals during development.
• perform affinity chromatography to purify a protein from crude cell extract
• perform size-exclusion chromatography for fine-grade purification of a protein from other
protein components
• determine the concentration of protein in a sample by UV absorbance spectroscopy
• perform enzymatic digestion and MALDI mass spectrometry to identify and localize stress-
induced covalent modifications to the primary structure of a purified protein
Competences
• discuss and critically evaluate the use of protein purification and protein analysis in the
scientific literature and during biopharmaceutical development.
• apply gel electrophoresis (SDS-PAGE) to identify protein components in a complex mixture
• employ analytical HPLC to determine protein purity and purification yield
• prepare and execute ESI and MALDI mass spectrometry to determine the molecular mass
and quality control of a purified protein
• apply fluorescence spectroscopy to assess the higher-order structure of a protein
Literature
• Lecture notes and research/review papers on purification and analysis of proteins available
on the course homepage
• Laboratory protocols and course appendix
• Chapters from the book: "Protein Analysis and Purification - Benchtop techniques". 2nd
edition, Ian M. Rosenberg. Birkhauser. 2005.
• Chapters from the book: "Methods for Structural Analysis of Protein Pharmaceuticals".
Edited by Wim Joskoot and Dan Crommelin. AAPS, 2005.
Recommended Academic Qualifications
The main academic prerequisites are a basic understanding of protein structure, bioorganic
chemistry, microbiology, thermodynamics (physical chemistry), and analytical chemistry.
Teaching and learning methods
• Lectures: 20 hrs
• Laboratory: 56 hrs
• Project work (individual study report): 20 hrs
Sign up
Self Service at KUnet
Open for credit transfer students and other external students. Apply here:
Credit transfer students:
http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/
Other external students:
http://healthsciences.ku.dk/education/exchange_guest_students/guest-students/
Credit transfer and other external students are welcomed on the course if there are seats
available and they have the academic qualifications.
Exam (SFKKIF002E - written examination)
Credit
7,5 ECTS
Type of assessment
Written examination, 1 hour under invigilation
Multiple Choice
The multiple choice-test is made up of a number (typically 25) of statements to which the student
has to decide whether they are true or false.
Exam registration requirements
• Participation in all laboratory exercises.
• In order to be able to take the exam, the laboratory group report and oral presentation of
the group report must be approved.
• In order to be able to take the exam, the student‘s report and oral presentation of the
"Independent Study Report" must be approved.
Aid
Without aids
There is access to the following at the exam on Peter Bangs Vej:
• Office (Word, Excel, Onenote and Powerpoint)
• IO2 – the digital pen
• Panoramic Viewer
• Paint
• Calculator – Windows' own
• R – Statistical programme
• MathType - formel programme
• Maple
• ITX MC – multiple choice programme
• Adobe reader usb-stick is not allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment
To pass the course the student must be able to:
Knowledge
• describe the primary structure, covalent modifications and higher-order structure of
proteins and how these determine protein function.
• understand the basic chemical and physical properties of proteins in solution (charge,
solubility, hydrophobicity, affinity).
• explain the principles of recombinant protein expression and the strengths/weaknesses of
different host cell systems.
• describe the common methods for protein purification and their underlying physical
principles for protein separation
• understand the common methods for analysis of protein primary structure and common
covalent modifications of proteins
• understand the common methods for analysis of higher order protein structure and
physical size/oligomerization.
• understand methods for quality control of protein biopharmaceuticals in the
pharmacopoiea.
• search bioinformatics databases for the aminoacid sequence, molecular mass and
chemical properties of a target protein
• search bioinformatics databases for structural information for a target protein and visaluze
higher-order protein structure using molecular graphics software.
Skills
• identify the strengths and weaknesses of different analytical methods to analyze the
primary or higher-order structure of protein biopharmaceuticals during development.
• perform affinity chromatography to purify a protein from crude cell extract
• perform size-exclusion chromatography for fine-grade purification of a protein from other
protein components
• determine the concentration of protein in a sample by UV absorbance spectroscopy
• perform enzymatic digestion and MALDI mass spectrometry to identify and localize stress-
induced covalent modifications to the primary structure of a purified protein
Competences
• discuss and critically evaluate the use of protein purification and protein analysis in the
scientific literature and during biopharmaceutical development.
• apply gel electrophoresis (SDS-PAGE) to identify protein components in a complex mixture
• employ analytical HPLC to determine protein purity and purification yield
• prepare and execute ESI and MALDI mass spectrometry to determine the molecular mass
and quality control of a purified protein
• apply fluorescence spectroscopy to assess the higher-order structure of a protein
Students requiring a grade for the exam, should contact the course responsible.
Workload
Category Hours
Lectures 20
Preparation 40
Practical exercises 56
Preparation 24
Exam 2
Preparation 64
Total 206
Course information
Language
English
Course code
SFKKIF002U
Credit
7,5 ECTS
Level
Full Degree Master
Duration
1 block
Placement
Block 2
The course is scheduled for fall 2019. The course will not run during 2018.
Schedule
A
Course capacity
32 students
Continuing and further education Study board
Study Board of Pharmaceutical Sciences
Contracting department
Department of Pharmacy
Course Coordinators
Kasper Dyrberg Rand (kasper.rand@sund.ku.dk)
Lecturers
Kasper D. Rand
Marco van de Weert
Osman Mirza
Saved on the 22-12-2017
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.
Accept af cookies fra ku.dk
Ku.dk bruger blandt andet cookies til at udarbejde statistik
over anvendelsen af sitet.
Accepter cookies Læs
mere om cookies på ku.dk
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige version.
SFKKIL007U Biopharmaceuticals: Design and
Modification of Biomacromolecules
Expand all Volume 2018/2019
Education
MSc Programme in Medicinal Chemistry - compulsory
MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and
cand.scient.pharm) - elective
MSc Programme in Pharmaceutical Sciences (English programme) - elective
Content
Besides an introduction to the concepts and methods that are relevant for investigating and
understanding the physicochemical and pharmacological properties of macromolecules the
course focus on the design, discovery and applicability of biopharmaceutical drugs, primarily
those based on peptides or proteins.
Furthermore, this course will form the basis for studies on optimization of pharmaceutical
properties of peptides, proteins and nucleic acids in relation to preclinial and clinical drug
development. Finally, drug leads derived from these classes of macromolecules (e.g.
peptidomimetics, oligonucleotide analogues and oligosaccharides) as well as relevant delivery
vehicles will be discussed.
These subjects will be introduced via lectures (based on book chapters and comprehensive
reviews and articles), while the class sessions will comprise student presentations and discussion
of selected scientific articles in order to facilitate an in-depth understanding of both theoretical
and practical aspects of biopharmaceutical drug research. In addition, some class sessions will
comprise theoretical execises on the basic elements of the course (e.g. peptide synthesis
and protein modification). Also, the course comprises three practical exercises in a chemical
synthesis lab. These exercises illustrates basic solid-phase peptide synthesis methodology and
protein modification. For each excercise a laboratory notebook should be kept in order to
facilitate writing of mandatory reports which also comprise answering specific questions and
interpretation of analytical results (LC-MS, MALDI and ELISA).
The most relevant compound classes and their applications are briefly outlined below:
• Peptide- and protein-based drugs, inculding modified peptide and proteins (primary
content of the course).
• Introduction to antibodies and therapeutic relevance.
• Oligonucleotides for gene therapy and antisense siRNA as putative biopharmaceutical
drugs.
Methods and concepts:
• Importance of structure for pharmacological activity and suitable drug properties: charge,
solubility, stability and delivery.
• Primary sequence and folding into secondary and tertiary structures and methods for
manipulating these.
• Principles of solid-phase peptide synthesis (incl. combinatorial and parallel approaches)
and optimization. Advanced peptide chemistry including selection of linkers, coupling
reagents and protecting groups.
• Protein biosynthesis and modification: post-translational and chemical transformations.
• Genetic and protein engineering as a discovery and production tool for biological protein
and peptide expression and modification.
• Practical manual solid-phase peptide synthesis and simple modification of proteins.
• Chemical protein synthesis and semisynthesis
Learning Outcome
The purpose of this course is to provide students with theoretical knowledge on
biopharmaceutical drug discovery as a central part of contemporary and future interdisciplinary
drug discovery efforts in academia as well as in the biotech and pharmaceutical industry.
The focus will primarily be on peptides and proteins as they currently constitute the most
important class of biopharmaceuticals.
An additional aim is to introduce students to methodologies related to chemical synthesis,
biological expression, and modification of biopharmaceuticals with a focus on their applications
in drug discovery and development.
At the end of the course, students are expected to be able to:
Knowledge
• comprehend the steps involved in biopharmaceutical drug discovery
• understand aspects of chemical peptide synthesis relevant for biopharmaceutical drug
discovery
• understand post-translational peptide/protein modifications
• understand methods used in chemical peptide and protein modification
• understand the concept of unnatural amino acid mutagenesis
• appreciate of the potential of novel types of biopharmaceuticals (e.g. nucleic acids and
analogs thereof) in sufficient detail to follow future scientific developments
Skills
• assess the implications of peptide/protein sequence on their folding into
secondary/tertiary structure
• search and read relevant literature and use this knowledge in biopharmaceutical research
projects.
• perform simple solid-phase peptide synthesis and protein modification
Competences
• read and discuss research examples concerning optimization of biologically active peptide
drug leads with respect to pharmacological properties including bioavailability and in vitro
cytotoxicity
• apply basic theory of peptide optimization and protein engineering/expression related to
practical development of biopharmaceuticals
Literature
Peptide Synthesis and Applications, K. J. Jensen, A. P. Tofteng, S. L. Pedersen (Eds), Springer
Protocols, Humana Press, 2013.
Selected book chapters:
Textbook of Drug Design and Discovery (CRC Press; eds. P. Krogsgaard-Larsen K. Strømgaard, U.
Madsen)
Pharmaceutical Formulation Development of Peptides and Proteins (CRC Press 2012; eds. L.
Hovgaard, S. Frøkjær, M. van de Weert)
Peptide and protein derivatives (p. 131-148), in Pharmaceutical Formulation Development of
Peptides and Proteins (Taylor & Francis 2012; eds. M. van de Weert, S. Frøkjær & L. Hovgaard)
Supplementary reviews and research papers covering the following topics:
Examples of subclasses of potential drug leads (peptides, peptidomimetics and proteins), known
biopharmaceuticals (e.g. peptide hormones, cytokines, antibodies, nucleic acids and analogues
thereof, as well as adjuvants/vaccines and drug delivery vehicles.
All teaching materials besides the textbook comprise parts of textbooks already used in other
courses concerning biopharmaceuticals, or it will be available via the course homepage or as
handout material.
Recommended Academic Qualifications
Basic knowledge in organic and bioorganic chemistry and molecular biology is a prerequisite.
Teaching and learning methods
Lectures: 21
Class sessions: 12
Writing of individual study report (ca. 40 hours during last 3 weeks)
Practical exercises (15 hours in lab)
Feedback form
Written
Individual
Upon grading of the essay (written assignment) the students will receive a performance scheme
(uploaded together with the grade in digital exam) stating which parts/features of the essay that
were: (i) very good, (ii) could be improved, (iii) was only just acceptable, or (iv) inacceptable.
Sign up
Self Service at KUnet
Open for credit transfer students and other external students. Apply here:
Credit transfer students:
http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/
Other external students:
http://healthsciences.ku.dk/education/exchange_guest_students/guest-students/
Credit transfer and other external students are welcomed on the course if there are seats
available and they have the academic qualifications.
Exam 1 (Lab exercises (continuous assessment))
Credit
0 ECTS
Type of assessment
Course participation
Course certificate: The students work in groups of 3-4 persons preparing a joint lab journal and
report on the performed experiments including answering of the associated questions.
Aid
All aids allowed
The lab teachers may be approached for guidance in answering the associated questions.
Marking scale
passed/not passed
Censorship form
No external censorship
Re-exam
Possibility for improving "not-approved" to "approved" before the MC exam takes place.
If "not-approved" not to a sufficient degree has been attempted improved to "approved" within
the associated examination period the experimental part of the course must be repeated.
Criteria for exam assesment
To obtain a course certificate the student must be able to:
Knowledge:
• show that the basic concepts have been understood through answering the associated
questions.
• show that the basic concepts have been understood.
• a theoretical background to understand synthesis descriptions of simple chemical
reactions involving peptides relevant as biopharmaceuticals.
Skills:
• carry out the laboratory work to satisfaction.
• perform experiments with acceptable results and described in a scientific way, so that the
synthesis and analysis excercises may be repeated.
• performing simple syntheses and analysis of peptides.
Competences:
• write a report in a scientific language how exsperimental work has been performed.
Exam 2 (SFKKIL007E - written assignment)
Credit
5 ECTS
Type of assessment
Written assignment
Individual written assignment (essay) in the format of a scientific minireview (size: min 15.000 and
max. 25.000 characters including spaces; supporting figures allowed) based on literature studies
on a subject agreed upon with one of the teachers and approved with the course directors. The
essay must relate to a substantial content of chemistry as well as a biology/biopharmaceutical
aspect. The student will have 3 weeks to prepare this.
Aid
All aids allowed
Marking scale
7- point grading scale
Censorship form
No external censorship
Criteria for exam assesment
To achieve the grade 12 the student must be able to:
Knowledge
• comprehend the steps involved in biopharmaceutical drug discovery
• understand of aspects of chemical peptide synthesis relevant for biopharmaceutical drug
discovery
• understand of post-translational peptide/protein modifications
• understand of methods used in chemical protein modification
• understand of the concept of unnatural mutagenesis
• appreciate the potential of novel types of biopharmaceuticals comprising nucleic acids (and
analogs thereof) and oligosaccharides in sufficient detail to follow future scientific
developments in these fields
Skills
• assess the implications of peptide/protein sequence on their folding into
secondary/tertiary structure
• device chemical synthesis of relevant peptides and modification of protein drugs
• search and read relevant literature and use this knowledge in biopharmaceutical research
projects.
• discuss and illustrate how a specific type of biopharmaceuticals may be discovered via
synthesis/expression of leads that undergo optimization using appropriate methodologies.
Competences
• read and discuss research examples concerning optimization of biologically active peptide
drug leads with respect to pharmacological properties including bioavailability and in vitro
cytotoxicity
• apply basic theory of peptide optimization and protein engineering/expression related to
practical development of biopharmaceuticals
Exam 3 (SFKKIL107E - written examination)
Credit
2,5 ECTS
Type of assessment
Written examination, 1 hour under invigilation
Multiple-choice test with 25-35 statements.
Aid
Without aids
There is access to the following at the exam:
• Office (Word, Excel, Onenote and Powerpoint)
• IO2 – the digital pen
• Panoramic Viewer
• Paint
• Calculator – Windows' own
• R – Statistical programme
• MathType formel programme
• Maple
• ITX MC – multiple choice programme
• Adobe reader UBS-stick is not allowed.
Marking scale
7- point grading scale
Censorship form
No external censorship
Criteria for exam assesment
To achieve the grade 12 the student must be able to:
Knowledge
• comprehend the steps involved in chemical peptide synthesis
• understanding properties and utility of specific commonly used reagents, building blocks
and protecting groups involved in chemical peptide synthesis
• understand post-translational peptide/protein modifications including reagents and
methods
• understand methods and specific common reagents used in chemical protein modification
• understand the concept and specific methods involved in unnatural mutagenesis
• understand basic concepts related to peptide optimization
• understand basic properties of peptidomimetics and biologically active peptides (e.g. AMPs
and CPPs)
• comprehend basic concepts, methods and properties related to nucleic acids (and analogs
thereof), antibodies, and vaccines
Skills
• assess utility and application of specific common reagents and methods related
to chemical peptide synthesis
• assess utility and application of specific common reagents and methods related
to modification of proteins
• assess concepts and specific methods involved in peptide optimization
• assess the properties of peptidomimetics and specific types of biologically active peptides
(e.g. AMPs and CPPs)
• assess basic concepts, methods and properties related to nucleic acids (and analogs
thereof), antibodies, and vaccines
Competences
• understand examples concerning biologically active peptide/protein drug leads with
respect to chemical synthesis/modification and optimization
• apply basic theory of peptide synthesis and optimization and protein engineering/
expression related to practical development of biopharmaceuticals
Workload
Category Hours
Lectures 21
Colloquia 8
Project work 40
Preparation 93
Exam 25
Laboratory 15
Theory exercises 4
Total 206
Course information
Language
English
Course code
SFKKIL007U
Credit
See exam description
Level
Full Degree Master
Duration
1 block
Placement
Block 1
Schedule
C
Course capacity
30 students (25 seats reserved students of MSc Programme in Medicinal Chemistry).
Continuing and further education Study board
Study Board of Pharmaceutical Sciences
Contracting department
Department of Drug Design and Pharmacology
Course Coordinators
Kristian Strømgaard (kristian.stromgaard@sund.ku.dk)
Christian Adam Olsen (cao@sund.ku.dk)
Lecturers
Kristian Strømgaard
Christian A. Olsen
Saved on the 22-12-2017
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.
Accept af cookies fra ku.dk
Ku.dk bruger blandt andet cookies til at udarbejde statistik
over anvendelsen af sitet.
Du kan altid slette cookies fra ku.dk igen.
Accepter cookies Læs
mere om cookies på ku.dk
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige version.
SFKKIF008U Biopharmaceuticals: Formulation of
Peptides and Proteins
Expand all Volume 2018/2019
Education
MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and
cand.scient.pharm) - elective
MSc Programme in Medicinal Chemistry - elective
MSc Programme in Pharmaceutical Sciences (English programme) - elective
Content
The programme module deals with pharmaceutical issues concerning the formulation of drugs
based on peptides and proteins. Students will also gain insight into analytical and production
problems as well as the regulatory aspects of registering biotechnological drugs.
The following topics will be dealt with:
A general introduction to the production methods used to produce peptides by synthesis.
Methods for optimizing the chemical and physical stability of peptides and proteins, including an
introduction to the analytical methods used for chemical and physical-chemical characterization
of these types of drugs.
There will be emphasis on formulation of solutions and freeze-dried preparations, and the
pharmaceutical formulation aspects of developing vaccines and alternative administration
methods are also included. Unwanted immunogenicity and pharmacokinetics of protein drugs
will be discussed.
The development of peptide and protein analogues will be covered.
There will be general description of the documentation necessary for the pharmaceutical-
chemical part of a registration application, with focus on the special conditions relevant to
biotechnological products.
For project work, students in groups of four to five will draft a development plan for a protein
drug from production of the drug (the protein) to registration, with the main focus on (pre-)
formulation work. Thus, the project work will include all of the aspects discussed during the
course, and must form the subject of a written report to be presented orally.
Learning Outcome
With focus on (pre-)formulation, the course describes the development of peptide- and protein-
based drugs from production.
At the end of the course, students are expected to:
Knowledge
• explain and discuss the principles of formulation for peptides and proteins
• explain and identify important degradation pathways of peptides and proteins
• explain and identify the most important methods for characterizing drugs based on
peptides and proteins
Skills
• outline the options for the formulation of peptides and proteins
• discuss and elaborate on the scientific literature in the field of peptide/protein formulation
Competencies
• make a development plan for a peptide or protein formulation
Literature
• Pharmaceutical formulation development of peptides and proteins, 2nd ed. S. Frokjaer, L.
Hovgaard, and Marco van de Weert, 2012, Taylor & Francis
• Selected articles and hand-outs available on the course homepage
Recommended Academic Qualifications
The main academic prerequisites are a basic understanding of protein structure, organic
chemistry, microbiology, thermodynamics (physical chemistry), and analytical chemistry.
Teaching and learning methods
Lectures: 34 hours
Project work: 34 hours
Seminars: 8 hours
Feedback form
Oral
Collective
Peer feedback (Students give each other feedback)
Sign up
Self Service at KUnet
Open for credit transfer students and other external students. Apply here:
Credit transfer students:
http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/
Other external students: http://healthsciences.ku.dk/education/exchange_guest_students/guest-
students/
Credit transfer and other external students are welcomed on the course if there are seats
available and they have the academic qualifications.
Exam (SFKKIF008U - continuous assessment)
Credit
7,5 ECTS
Type of assessment
Course participation under invigilation
Written assignment
Course certificate:
Report and presentation of project work. Students are expected to actively participate in the
learning process, that is, in the lectures and in group work (literature searches, discussions within
the group, writing, presenting and defending the report). The students must also participate in a
minimum of 26 hrs of lectures and in all group presentations.
An attendance scheme will log sufficient attendance. Active participation requires a signed
declaration in the report of all group members that all group members actively participated. The
report must follow the guidelines layed out in the description of the group work. All group
members must act as opponents to one other group.
Students with insufficient attendance or insufficient contribution in the group work may be given
extra assignments, such as written evaluation of the report of other groups or short summaries
of lecture notes and/or book chapters on specific topics.
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment
To pass the course the student must be able to:
Knowledge
• explain and discuss the principles of formulation for peptides and proteins
• explain and identify important degradation pathways of peptides and proteins
• explain and identify the most important methods for characterizing drugs based on
peptides and proteins
Skills
• outline the options for the formulation of peptides and proteins
• discuss and elaborate on the scientific literature in the field of peptide/protein formulation
Competencies
• make a development plan for a peptide or protein formulation
Workload
Category Hours
Lectures 34
Project work 34
Seminar 8
Preparation 130
Total 206
Course information
Language
English
Course code
SFKKIF008U
Credit
7,5 ECTS
Level
Full Degree Master
Duration
1 block
Placement
Block 1
Schedule
B
Course capacity
60 students
Continuing and further education
Study board
Study Board of Pharmaceutical Sciences
Contracting department
Department of Pharmacy
Course Coordinators
Marco van de Weert (marco.vandeweert@sund.ku.dk)
Study secretary: Malthe Sørensen (studieservice-UP2@sund.ku.dk)
Lecturers
Marco van de Weert, Lene Jørgensen, Hanne Mørck Nielsen, Camilla Foged, Kasper Dyrberg Rand,
Vito Foderà, and various industrial lecturers
Saved on the 31-08-2017
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige version.
SFKKM9011U Computational Medicinal Chemistry
Expand all Volume 2018/2019
Education
MSc Programme in Medicinal Chemistry - compulsory
MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and
cand.scient.pharm) - elective
MSc Programme in Pharmaceutical Sciences (English programme) - elective
Content
The course focuses on molecular modelling techniques and their use in modern drug research,
illustrated through lectures, exercises, and project work. In the lectures, the students are
introduced to the fundamental principles behind the methods in molecular modeling. In the
exercises, the students get hands-on experience with modern computer-based tools, and the
project work gives the opportunity to apply these tools on a drug targets with the aim of
understanding and improving the binding to a protein target.
The methods covered in the lectures, exercises, and project work are:
• investigating bioactive conformations of drug-like molecules
• analyzing molecular characteristics of ligands and protein binding sites
• structure-based drug design and ligand-based drug design
• pharmacophore development and quantitative structure activity relationships (QSAR)
• homology modelling
• docking of ligands into the binding pocket of the target protein.
• investigating protein-protein interfaces relevant for biopharmaceutics
Objective
The course is relevant for research within the drug discovery area and other areas where it is
important to:
• have knowledge about experimental and theoretical methods that can be used to analyze
molecular characteristics of biologically important molecules
• understand the interactions between ligands and biomacromolecules
• get hands-on experience with modern tools in molecular modeling to achieve skills to
develop new compounds
Learning Outcome
At the end of the course, students will be able to:
Knowledge
• explain the characteristics that influence the relationship between molecular structure and
biological activity
• be critical to the principles and methods used for rational discovery and development of
new or better drugs
Skills
• use and critically evaluate results achieved from structure determination of proteins and
drug-related compounds
• use and critically evaluate results obtained with modern computer-based methods for
structure-activity analysis of biologically active compounds
• have hands-on experience with modern tools in molecular modeling.
Competences
• plan a computer-based project on how to improve binding to a target
• apply the computer-based tools for projects in drug discovery
• select the appropriate molecular modelling techniques in modern drug research
Literature
• Reviews and scientific papers available at the course website
• Supplementary notes (notes with additional information on methods used – to be
downloaded from course homepage)
Formal requirements
non.
Recommended Academic Qualifications
Teaching is organized on the assumption that students have already acquired knowledge in
medicinal and biostructural chemistry, including protein structures, biophysical techniques,
protein-ligand interactions, and basic organic and physical chemistry. No special skills for
computer programming are needed. Software with graphic user interfaces will be used.
Teaching and learning methods
•Lectures: 19 hours
•Computer exercises: 19 hours
•Project work: 77 hours
•Supervision during project work: guidelines will be available on the course homepage
•Exam: 0,5 hours
Feedback form
Oral
Continuous feedback during the course of the semester
Feedback by final exam (In addition to the grade)
Computer exercises: There will be feedback after each computer exercise both from teacher and
as a digital quiz.
Lectures: Digital quizzes are used as a supplement to the lectures.
Project work: Initially, a project plan is discussed with the teachers, and during the project period
there will be progress discussions. In addition, the students will present and discuss the status of
the project for teachers and the other participants in the course.
Sign up
Self Service at KUnet
Open for credit transfer students and other external students. Apply here:
Credit transfer students:
http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/
Other external students:
http://healthsciences.ku.dk/education/exchange_guest_students/guest-students/
Credit transfer and other external students are welcomed on the course if there are seats
available and they have the academic qualifications.
Exam (SFKKM9011E - oral examination)
Credit
7,5 ECTS
Type of assessment
Oral examination, 30 min
Individual 30 minutes oral exam (assessment included) with a presentation of project work
(based on the poster) as starting point for the exam, followed by an examination in the methods
presented and used during the course, i.e. all the written course material. The student is
expected to present:
- detailed knowledge of specified topics in the course material,
- basic knowledge of the rest of the course material, and
- detailed knowledge of own project
Aid
All aids allowed
Marking scale
7- point grading scale
Censorship form
No external censorship
Criteria for exam assesment
To achieve the grade 12 the student must be able to:
Knowledge
• explain the characteristics that influence the relationship between molecular structure and
biological activity
• be critical to the principles and methods used for rational discovery and development of
new or better drugs
Skills
• be able to use and critically evaluate results achieved from structure determination of
proteins and drug-related compounds
• be able to use and critically evaluate results obtained with modern computer-based
methods for structure-activity analysis of biologically active compounds
• have hands-on experience with modern tools in molecular modeling.
Competences
• plan a computer-based project on how to improve binding to a target
• apply the computer-based tools for projects in drug discovery
• select the appropriate molecular modelling techniques in modern drug research
Workload
Category Hours
Lectures 19
Theory exercises 19
Preparation 70
Project work 77
Exam 21
Total 206
Course information
Language
English
Course code
SFKKM9011U
Credit
7,5 ECTS
Level
Full Degree Master
Duration
1 block
Placement
Block 4
Schedule
C
Course capacity
54 students ( 25 seats reserved students at the MSc Programme in Medicinal Chemistry).
Continuing and further education Study board
Study Board of Pharmaceutical Sciences
Contracting department
Department of Drug Design and Pharmacology
Course Coordinators
Karla Andrea Frydenvang (karla.frydenvang@sund.ku.dk)
Study secretary: Jeanette Bangsbøll Dunn (studieservice-UP2@sund.ku.dk)
Saved on the 22-12-2017
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.
Accept af cookies fra ku.dk
Ku.dk bruger blandt andet cookies til at udarbejde statistik
over anvendelsen af sitet.
Du kan altid slette cookies fra ku.dk igen.
Accepter cookies Læs
mere om cookies på ku.dk
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige version.
SFKKIF105U Entrepreneurship in Pharmaceuticals
Expand all Volume 2018/2019
Education
MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and
cand.scient.pharm) - elective
MSc Programme in Medicinal Chemistry - elective
MSc Programme in Pharmaceutical Sciences (English programme) - elective
Content
This course is designed for students who want to learn about idea development, entrepreneurship,
and start-up processes within the pharmaceuticals (and related (bio) technologies) area. While
intellectual property rights form an important part of the content, the scope of the course is
broader than this, emphasizing an overview of entrepreneurship within the area, in which
intellectual property constitutes one of a number of aspects.
Theory sessions will include an introduction to i) innovation management tools, ii) entrepreneurship
models, iii) a variety of toolboxes for entrepreneurs, and iv) pharmaceuticals as a business area.
Furthermore, conditions for discovery, intellectual property rights, and patenting are introduced,
covering the structure of patent applications and concepts such as objective novelty, priority
principle, and inventive step. An account is also made of various aspects of patent literature, as
well as approaches to and searches within the pharmaceutical area. Moreover, legal framework
related to establishing a company in Denmark will be introduced, as will licencing and typical
pitfalls in contracts. These theoretical sessions will be complemented by illustrative case studies. In
parallel, students will apply these tools to develop a venture idea in groups of 3-5 students through
project work, in-class exercises, and interaction with
stakeholders, including considerations of i) intellectual property rights, ii) market/competition, iii)
scientific/technical development aspects, iv) clinical trial plans, and v) investment strategies,
ultimately resulting in the development of a business plan.
The purpose of the course is to provide students interested in developing their own ventures
and/or in entrepreneurial and innovation processes with a set of tools they can use to engage in
new ventures or innovation teams within the pharmaceutical area. Moreover, the course aims to
provide an overview of the significance of intellectual property rights in pharmaceutical research
and development. This is linked to current developments within pharmaceutical industry, how
this relates to entrepreneurial opportunities, as well as to strategic considerations of
market/competition, scientific/technical development aspects, clinical trial plans, and investment
strategies, illustrated by business case studies. To set this in practice, the students will develop a
business plan in groups of 3-5, to be presented/pitched and provided feedback on by other
students and the course team. thisFor this, students may either have an idea beforehand or will be
able to develop an idea with help from the course team. To facilitate the business plan
development, and to secure progression, a mid-course assessment will be held, and feedback
provided to the groups for the finalization of the business plans. The final outcome is that students
will be able to build on the knowledge and teamwork experiences from the course during their
entrepreneurial career, and in further graduate courses on specific topics within innovation,
entrepreneurship, and business development.
Learning Outcome
On completion of the course the student will be able to: Knowledge
• show an overview of concepts in entrepreneurship, developments in the pharmaceutics
area, and business opportunities related to this.
• explain principles of intellectual property rights and international patenting systems.
• explain the importance of an active intellectual property rights strategy for
pharmaceuticals (and related (bio)technologies) business development.
• show an overview of business development aspects, particularly relating to start-ups, in the
pharmaceutic area.
Skills
• assess current developments within pharmaceutical industry, and how this translates into
entrepreneurial business opportunities.
• identify innovative elements and its relationship to intellectual property rights.
• use professional databases to find relevant patents and patent applications.
• read and interpret patents and patent applications to assess the strengths/weaknesses and
freedom-to-operate situation.
• communicate ideas to stakeholders, including team members, investors, customers,
collaborators, and other potential partners
Competences
• provide an overview familiarity with the process of pharmaceuticals development.
• analyze and integrate open innovation and business model concepts and practices to
understand, on a basic level, how pharmaceutical companies operate and compete in the
market.
• navigate in the patent landscape surrounding a product and explain the different stages of
the patenting process, and requirements for obtaining a patent.
• analyze the commercial potential of inventions based on technological and medical
considerations, IP situation, and market analyses.
• describe and compare the different means to fund or finance inventions in order to
commercialize these including an introduction to business plans and raising venture capital
for the new company.
• develop and present a business plan integrating the aspects above.
• interact with external partners, both industrial and academic, as well as in virtual
organizations.
Literature
Selected documents including review articles, patent applications, and supplementary notes.
Recommended Academic Qualifications
The course is designed to give students from a broad introduction to entrepreneurship within the
pharmaceuticals (and related (bio)technologies) area, and no prerequisites with
entrepreneurship are required. Students are expected to have a relevant background (e.g., from
the pharmaceutical, life, or health sciences).
Teaching and learning methods
Class and guest lectures will provide students with an overview of current developments within
pharmaceutical industry, and how these translate into entrepreneurial opportunities. They will also
cover aspects of intellectual property rights, stakeholder interactions, and business strategy
considerations, illustrated with case stories. As a core integrating activity of the course, students
will develop a business plan on a venture idea, integrating these aspects, and give a
presentation/pitch of their project. Furthermore, students will give and receive feedback on their
project work, will need to learn how to work and organize themselves in teams, and will practice to
communicate their business ideas.
Requirements regarding active participation
•Active with regards to questions and discussions in relation to lectures
and guest lectures
Business plan development (done in groups of 3-5)
- Active during group meetings with the group mentor
- Active in material generation, analysis, and business plan writing
- Active (presentation and questions/discussions) in half-time andfinal workshops
- Clear and substantial contributions to final business plan, and shared responsibility of overall
business plan
Two oral presentations (group-wise, but individual contributions required, one at half-time
seminar and one at final seminar, where business plan is presented orally. In addition, each group
should hand in a written business plan/report.
Report evaluated on a group level, but activity and progress evaluated individually.
Feedback form
Written Oral
Individual Collective
Continuous feedback during the course of the semester
Peer feedback (Students give each other feedback)
Sign up
Self Service at KUnet
Open for credit transfer students and other external students. Apply here: Credit
transfer students:
http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/ Other
external students: http://healthsciences.ku.dk/education/exchange_guest_students/guest-
students/
Credit transfer and other external students are welcomed on the course if there are seats
available and they have the academic qualifications.
Exam (SFKKIF105U - continuous assessment)
Credit
7,5 ECTS
Type of assessment
Oral examination, 20 minutes Course
participation
Continuous assessment includes:
•development of a business plan in groups of 3-5
•oral group presentation of the partial business plan (mid-course evaluation)
•feedback to other groups’ business plan
•oral group presentation of the final business plan
•presence during lectures
•active partipation during the course
Oral presentation of the partial business plan (mid-course evaluation). Weight: 25%. Oral
presentation of the business plan developed. Weight:
Aid
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment
On completion of the course the student will be able to: Knowledge
• show an overview of concepts in entrepreneurship, developments in the pharmaceutics
area, and business opportunities related to this.
• explain principles of intellectual property rights and international patenting systems.
• explain the importance of an active intellectual property rights strategy for
pharmaceuticals (and related (bio)technologies) business development.
• show an overview of business development aspects, particularly relating to start-ups, in the
pharmaceutic area.
Skills
• assess current developments within pharmaceutical industry, and how this translates into
entrepreneurial business opportunities.
• identify innovative elements and its relationship to intellectual property rights.
• use professional databases to find relevant patents and patent applications.
• read and interpret patents and patent applications to assess the strengths/weaknesses and
freedom-to-operate situation.
• communicate ideas to stakeholders, including team members, investors, customers,
collaborators, and other potential partners
Competences
• provide an overview familiarity with the process of pharmaceuticals development.
• analyze and integrate open innovation and business model concepts and practices to
understand, on a basic level, how pharmaceutical companies operate and compete in the
market.
• navigate in the patent landscape surrounding a product and explain the different stages of
the patenting process, and requirements for obtaining a patent.
• analyze the commercial potential of inventions based on technological and medical
considerations, IP situation, and market analyses.
• describe and compare the different means to fund or finance inventions in order to
commercialize these including an introduction to business plans and raising venture capital
for the new company.
• develop and present a business plan integrating the aspects above.
• interact with external partners, both industrial and academic, as well as in virtual
organizations.
• integrating the aspects above.
Workload
Category Hours
Lectures 20
Preparation 90
Project work 80
Colloquia 7
Guidance 9
Total 206
Course information
Language
English
Course code
SFKKIF105U
Credit
7,5 ECTS
Level
Full Degree Master
Duration
1 block
Placement
Block 3
Schedule
B
Course capacity
30 students
Continuing and further education Study board
Study Board of Pharmaceutical Sciences
Contracting department
Department of Pharmacy
Course Coordinators
Martin Malmsten (martin.malmsten@sund.ku.dk)
Study secretary: Malthe Sørensen (studieservice-UP2@sund.ku.dk)
Saved on the 22-12-2017
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige version.
SFKKIL008U Klinisk farmaci
Fold alle ud Årgang 2018/2019
Engelsk titel
Clinical Pharmaci
Uddannelse
kandidatuddannelsen i farmaci - valgfri
kandidatuddannelsen i farmaceutisk videnskab - valgfri
MSc Programme in Pharmaceutical Sciences (English programme) - elective
MSc Programme in Medicinal Chemistry - elective
Kursusindhold
• Introduktionsseminar 1 x 45 min
• Kliniske forelæsninger 8 x (2 x 45 min)
• Introduktion til praktik ophold 1 x 50 min
• 1 uges praktikophold
• Evalueringsseminar (klinisk del) 4 x 50 min
• Farmakoterapi forelæsninger 7 x (2 x 45 min)
• Farmakoterapi - intro til projektarbejde 2 x 50 minutter
• Evalueringsseminar (farmakoterapidel) 4 x 50 minutter
Målbeskrivelser
Formålet med studieenheden er at give de studerende indsigt i patienters sygdomssituation, så
de kan vurdere den medicinske behandling og herudfra give faglig vejledning til patienten, lægen
og andre, der er involveret i patientens medicinske behandling Studieenhedens formål er
endvidere at give de studerende tilstrækkelig klinisk baggrund til at kunne fungere i
medicinalindustrien inden for de farmaceutiske og kliniske områder, samt at samarbejde med
læger og sygeplejersker i den primære og sekundære sundhedstjeneste.
Efter endt kursus forventes den studerende at kunne:
Viden
• anvende fagene patologi, fysiologi, farmakologi og farmaci i forbindelse med den praktiske
anvendelse af lægemidler i patientbehandlingen
• beskrive sygdomme, deres medicinske behandling, pleje af patienter, brugen af
laboratoriedata og på baggrund heraf evaluere den medicinske behandling
Færdigheder
• deltage i beslutninger angående patienters lægemiddelterapi og vurdere
administrationsform og dosisregime.
• rådgive patienter og sundhedspersonale om optimal anvendelse af lægemidler
• udføre en medicingennemgang og evaluere den medicinske behandling
Kompetencer
• opnå indsigt og forståelse for samarbejdet mellem kliniske specialer (f.ex intensiv terapi og
klinisk mikrobiologi) og samarbejdet mellem de forskellige sundhedsprofessioner
• diskutere lægemidlers formuleringsmæssige egenskaber og de fysiologiske forholds
indflydelse på lægemiddelstoffets afgiftshastighed, absorption og effekt.
• diskutere formuleringsprincippet for et lægemiddel i relation til lægemidlets kliniske
anvendelse.
Undervisningsmateriale
• R. Walker & C. Edwards, Clinical Pharmacy and Therapeutics, 4rd ed. 2007, Churchill
Livingstone, ISBN-13: 9780443102851
• Behandlingsvejledninger fra IRF's og medicinske selskabers hjemmesider
• Forelæsningsnoter: Lægges på kursushjemmesiden
Anbefalede faglige forudsætninger
Undervisningen er tilrettelagt under den forudsætning, at de studerende har opnået en viden
svarende til indholdet i følgende studieenheder: Lægemiddelformulering, farmakologi (almen og
organrelateret), og farmakoterapi.
Undervisningsform
•Introduktionsseminar 1 x (2 x 50 min)
•Kliniske forelæsninger 8 x (2 x 45min) sammen med FFKKB9011 (Klinisk Praktik)
•1 uges praktikophold
•Evalueringsseminar (klinisk del) 4 x 50 min
•Farmakoterapi forelæsninger 7 x (2 x 45 min)
•Farmakoterapi - intro til projektarbejde 2 x 4 timer
•Evalueringsseminar (farmakoterapidel) 2x 50 minutter
Bemærkninger
Det faglige indhold i kurset overlapper med Pharmacotherapy Practise.
Feedbackform
Mundtlig
Individuel
Kollektiv
Peerfeedback (studerende giver hinanden feedback)
Tilmelding
Selvbetjeningen på KUnet
Udbydes til merit- og tompladsstuderende. Søg via disse links:
http://sund.ku.dk/uddannelse/vejledning-information/meritstuderende/
http://sund.ku.dk/uddannelse/efter-og-videreuddannelser/enkeltfag/ Der er
kun begrænset eller ingen pladser til eksterne studerende.
Eksamen (SFKKIL008U - løbende bedømmelse)
Point
7,5 ECTS
Prøveform
Kursusdeltagelse
Skriftlig aflevering
For at opnå kursusattest skal den studerende:
- Udvise tilfredsstillende deltagelse ved seminaret.
- Udvise tilfredsstillende gennemført klinikophold (fremmøde hele ugen)
- Aflevere en tilfredsstillende individuel skriftlig rapport over klinikopholdet samt aflægge en
individuel mundtlig fremlæggelse og diskussion af rapportens indhold.
- Aflevere en tilfredsstillende grupperapport over et udvalgt lægemiddel til en udvalgt patient
samt aflægge en tilfredsstillende gruppevis mundtlig præsentation og efterfølgende diskussion af
rapportens indhold.
Bedømmelsesform
bestået/ikke bestået
Censurform
Ingen ekstern censur
Kriterier for bedømmelse
For at bestå kurset skal den studerende kunne:
Viden
• anvende fagene patologi, fysiologi, farmakologi og farmaci i forbindelse med den praktiske
anvendelse af lægemidler i patientbehandlingen
• beskrive sygdomme, deres medicinske behandling, pleje af patienter, brugen af
laboratoriedata og på baggrund heraf evaluere den medicinske behandling
Færdigheder
• deltage i beslutninger angående patienters lægemiddelterapi og vurdere
administrationsform og dosisregime.
• rådgive patienter og sundhedspersonale om optimal anvendelse af lægemidler
• udføre en medicingennemgang og evaluere den medicinske behandling
Kompetencer
• opnå indsigt og forståelse for samarbejdet mellem kliniske specialer (f.ex intensiv terapi og
klinisk mikrobiologi) og samarbejdet mellem de forskellige sundhedsprofessioner
• diskutere lægemidlers formuleringsmæssige egenskaber og de fysiologiske forholds
indflydelse på lægemiddelstoffets afgiftshastighed, absorption og effekt.
• diskutere formuleringsprincippet for et lægemiddel i relation til lægemidlets kliniske
anvendelse.
Arbejdsbelastning
Kategori Timer
Forelæsninger 32
Forberedelse 82
Praktiske øvelser 42
Projektarbejde 50
I alt 206
Kursusinformation
Sprog
Dansk
Kursuskode
SFKKIL008U
Point
7,5 ECTS
Niveau
Kandidat
Varighed
1 blok
Placering
Blok 1
Skemagruppe
A (tirs 8-12 + tors 8-17) og B
Særlige forhold: Af hensyn til planlægningen af klinikopholdet skal den studerende, som ønsker
at følge andre kurser i blok 1, være opmærksom på at vælge et kursus, hvor der ikke er mødepligt
i uge 40 eller 41 samt tirsdage kl. 8-12 og torsdage kl. 8-17 men kun i september.
Kursuskapacitet
36 studerende
Efter- og videreuddannelse Studienævn
Studienævn for de Farmaceutiske Videnskaber
Udbydende institut
Institut for Lægemiddeldesign og Farmakologi
Kursusansvarlige
Lona Louring Christrup (llc@sund.ku.dk)
Study secretary: Malthe Sørensen (studieservice-UP2@sund.ku.dk)
Gemt den 22-12-2017
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.
Accept af cookies fra ku.dk
Ku.dk bruger blandt andet cookies til at udarbejde statistik
over anvendelsen af sitet.
Du kan altid slette cookies fra ku.dk igen.
Accepter cookies Læs
mere om cookies på ku.dk
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige version.
SLVKB0381U Methods and Procedures in Clinical Drug
Development
Expand all Volume 2018/2019
Education
MSc Programme in Pharmaceutical Sciences: Track III (English programme) - compulsory
MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and
cand.scient.pharm) - elective
MSc Programme in Medicinal Chemistry - elective
MSc Programme in Pharmaceutical Sciences (English programme) - elective
Content
The regulatory guidelines and principles around pre-clinical and clinical research will be
reviewed. During the last weeks of the course, the students will develop a clinical trial protocol
based on a medical case and prepare a project report. The core focus areas will be:
• Regulatory requirements for clinical trial protocols in Denmark and abroad
◦ The Danish Medicines Agency
◦ The Ethics Committee system
◦ Data Protection Agency
• Principles for the development of pre-clinical documentation
◦ Drug discovery
◦ Preclinical safety pharmacology and toxicology
• Clinical drug development
◦ Clinical research methodology – the randomised clinical study design
◦ Clinical trials
◾ Human pharmacology
◾ Therapeutic exploratory
◾ Therapeutic confirmatory
◾ Therapeutic use
◾ Health economics and outcomes studies
◦ Good Clinical Practice
◦ The pharmaceutical industry’s involvement in clinical development plans and
protocols
◦ The conduct and monitoring of clinical trials
◦ Clinical supply chain activities and study drug management
◦ Safety surveillance and pharmacovigilance
◦ Clinical research from the investigator perspective
◦ Data management
◦ Medical writing and study publications
◦ Medical devices
◦ Quality assurance, audits and inspections
Learning Outcome
The aim of the course is to give students knowledge about the preclinical and clinical
methodology used to generate the evidence necessary for getting marketing authorisation of a
drug. Furthermore, to give insight into the ethical, regulatory and guideline framework around
clinical drug development. The course provides a description of the main areas, processes and
key functions in the pharmaceutical industry that contributes to the planning, design and
practical conduct of clinical trials.
After completing the course the student is expected to be able to:
Knowledge
• explain preclinical and clinical research methods used as basis for the approval of drugs.
• explain ethical, regulatory and guideline requirements of clinical studies.
• define, summarize and identify the main areas, processes and key functions in the
pharmaceutical industry that contributes to planning, design and practical conduct of
clinical drug development.
Skills
• describe and analyze the regulatory requirements for pre-clinical and clinical trials used to
register drugs.
• put structure to and evaluate the clinical development process of a drug in the
pharmaceutical industry
• describe and master the main principles of Good Clinical Practice, including
roles/responsibilities of sponsors, monitors and investigators.
• assess and discuss the main quality assurance aspects and ethical dimensions of
importance in clinical drug development.
Competences
• independently develop, plan, coordinate and implement clinical trial protocols for studies
in healthy volunteers and patients across all 4 phases of Drug Development.
Literature
Laws, documents, recommendations, circulars, guidelines and scientific papers.
Formal requirements
Non.
Recommended Academic Qualifications
Course teaching is based on the assumption that students have knowledge corresponding to the
content of the courses Basic Pharmacology, Organ-related Pharmacology, Pharmacotherapy,
Toxicology and Drug Production.
Teaching and learning methods
Lectures: 40
Classroom discussions: 6
Case project and report: 70
Feedback form
Oral
Continuous feedback during the course of the semester
Peer feedback (Students give each other feedback)
Sign up
Self Service at KUnet
Open for credit transfer students and other external students. Apply here:
Credit transfer students:
http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/
Other external students:
http://healthsciences.ku.dk/education/exchange_guest_students/guest-students/
Credit transfer and other external students are welcomed on the course if there are seats
available and they have the academic qualifications.
Exam (SLVKB0381U Continuous Assessment)
Credit
7,5 ECTS
Type of assessment
Written assignment
Course participation
In order to obtain the course certificate the students should:
* develop a project report of clinical trial protocol based on a medical case. The report will be
developed during the last weeks of the course.
* Participate in the internal evaluation of the project report
* Participate satisfactorily throughout the course.
Participation in group work and presentation of project report is mandatory.
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment
To obtain a course certificate the student must be able to:
Knowledge
• explain preclinical and clinical research methods used as basis for the approval of drugs.
• explain ethical, regulatory and guideline requirements of clinical studies.
• define, summarize and identify the main areas, processes and key functions in the
pharmaceutical industry that contributes to planning, design and practical conduct of
clinical drug development.
Skills
• describe and analyze the regulatory requirements for pre-clinical and clinical trials used to
register drugs.
• put structure to and evaluate the clinical development process of a drug in the
pharmaceutical industry
• describe and master the main principles of Good Clinical Practice, including
roles/responsibilities of sponsors, monitors and investigators.
• assess and discuss the main quality assurance aspects and ethical dimensions of
importance in clinical drug development.
Competences
• independently develop, plan, coordinate and implement clinical trial protocols for studies
in healthy volunteers and patients across all 4 phases of Drug Development.
Workload
Category Hours
Lectures 40
Preparation 80
Theory exercises 6
Preparation 10
Project work 70
Total 206
Course information
Language
English
Course code
SLVKB0381U
Credit
7,5 ECTS
Level
Full Degree Master
Duration
1 block
Placement
Block 2
Schedule
B
Course capacity
60 students (20 seats reserved students from MSc Programme in Pharmaceutical Sciences: Track
III)
Continuing and further education Study board
Study Board of Pharmaceutical Sciences
Contracting department
Department of Drug Design and Pharmacology
Course Coordinators
Morten Andersen (morten.andersen@sund.ku.dk)
Saved on the 27-11-2017
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige version.
SFKKB9001U Pharmacokinetics and
Pharmacodynamics
Expand all Volume 2018/2019
Education
MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and
cand.scient.pharm) - elective
MSc Programme in Medicinal Chemistry - elective
MSc Programme in Pharmaceutical Sciences (English programme) - elective
Content
Lectures covering PK-PD relationships, as well as distribution, metabolite kinetics, effect at
receptor and ionchannel level, effect measurement, dose-effect relationships, population
methods, simulation of PK-PD relationships and variability in PK-PD response and dosing to
different patient populations.
Computer sessions for pharmacokinetic pharmacodynamic modeling using the program Phoenix
WinNonlin and Microsoft Excel.
Learning Outcome
At the end of the course, students are expected to be able to:
Knowledge
• demonstrate knowledge of pharmacokinetic (PK) and pharmacodynamic (PD) in the
individual as well as the population
• understand how to calculate PK and PD parameters and use them in a quantitative
description of the interaction between a drug and the body over time.
• obtain knowledge on variability in patient populations
Skills
• obtain insight and hands-on experience with pharmacokinetic and –dynamic data analysis,
based on different examples of plasma concentration-time course linked to therapeutic
response.
• obtain experience with the modelling software Phoenix WinNonlin and Microsoft Excel for
data analysis.
• apply knowledge on variability in patient populations to a PKPD analysis that can be used
to describe variability in response in different patient segments and in drug research and
illustrate development within the pharmaceutical industry.
Competences
• design dosing strategies in different clinical situations based on their knowledge about
PKPD (e.g. taking variations such as demographics, organfunction, pharmacogenetics,
comobidity and interactions into account).
• design experiments for the drug research and development based on their knowledge
about PKPD
Literature
• M. Rowland and T. Tozer, Clinical Pharmacokinetics and Pharmacodynamics, ed. 4, 2011
• Notes and lecture hand-outs available on the course homepage
Recommended Academic Qualifications
Participation and exam in either Basic Pharmacology or Principles of Pharmacology or similar, as
the student should be familiar with the basic pharmacokinetic parameters and calculations,
concepts determining variability in order to suggest individual dosing as well as knowledge and
competence for reasoning on PKPD information
Teaching and learning methods
Lectures: 21 lectures
Tutorials/computer sessions: 15 hours
Feedback form
Oral
Der gives løbende mundtlig feedback ved diskussion ved opgaveregningstimer og
computerøvelser
Sign up
Self Service at KUnet
Open for credit transfer students and other external students. Apply here:
Credit transfer students:
http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/
Other external students:
http://healthsciences.ku.dk/education/exchange_guest_students/guest-students/
Credit transfer and other external students are welcomed on the course if there are seats
available and they have the academic qualifications.
Exam (SFKKB9001E - written examination)
Credit
7,5 ECTS
Type of assessment
Written examination, 3 hours under invigilation
Examiners: Course teachers
Aid
Written aids allowed
Permitted aids: Textbooks, all written course material from the homepage.
There is access to the following at the exam on Peter Bangs Vej:
• Office (Word, Excel, Onenote and Powerpoint)
• IO2 – the digital pen
• Panoramic Viewer
• Paint
• Calculator – Windows' own
• R – Statistical programme
• ITX MC – multiple choice programme
• Adobe reader
• MathType formel programme
• Maple
• USB access – for usb stick with notes etc.
Marking scale
7- point grading scale
Censorship form
No external censorship
Criteria for exam assesment
To achieve the grade 12 the student must be able to:
Knowledge
• demonstrate knowledge of pharmacokinetic (PK) and pharmacodynamic (PD) in the
individual as well as the population
• understand how to calculate PK and PD parameters and use them in a quantitative
description of the interaction between a drug and the body over time.
• obtain knowledge on variability in patient populations
Skills
• obtain insight and hands-on experience with pharmacokinetic and –dynamic data analysis,
based on different examples of plasma concentration-time course linked to therapeutic
response.
• obtain experience with the modelling software Phoenix WinNonlin and Microsoft Excel for
data analysis.
• apply knowledge on variability in patient populations to a PKPD analysis that can be used
to describe variability in response in different patient segments and in drug research and
illustrate development within the pharmaceutical industry.
Competences
• design dosing strategies in different clinical situations based on their knowledge about
PKPD (e.g. taking variations such as demographics, organfunction, pharmacogenetics,
comobidity and interactions into account).
• design experiments for the drug research and development based on their knowledge
about PKPD
Workload
Category Hours
Lectures 21
Exam 3
Preparation 167
Theory exercises 15
Total 206
Course information
Language
English
Course code
SFKKB9001U
Credit
7,5 ECTS
Level
Full Degree Master
Duration
1 block
Placement
Block 1
Schedule
A
Course capacity
30 students
Continuing and further education
Study board
Study Board of Pharmaceutical Sciences
Contracting department
Department of Drug Design and Pharmacology
Course Coordinators
Trine Meldgaard Lund (trine.lund@sund.ku.dk)
Study secretary: Malthe Sørensen (studieservice-UP2@sund.ku.dk)
Saved on the 22-12-2017
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.
Accept af cookies fra ku.dk
Ku.dk bruger blandt andet cookies til at udarbejde statistik
over anvendelsen af sitet.
Du kan altid slette cookies fra ku.dk igen.
Accepter cookies Læs
mere om cookies på ku.dk
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan se,
du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har brug for,
er linket til den offentlige version. Kontakt venligst den person, der har givet dig linket (eller
den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte offentlige version.
SFKKA9021U Principles and Practice of Bioanalysis
Expand all Volume 2018/2019
Education
MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and
cand.scient.pharm) - elective
MSc Programme in Medicinal Chemistry - elective
MSc Programme in Pharmaceutical Sciences (English programme)- elective
MSc Programme in Environmental Science (SCIENCE) - restricted elective
Content
The course is intended for (a) students specializing in bioanalysis (determination of
pharmaceuticals in biological fluids), and for (b) students with need for improved general
knowledge and skills in analytical chemistry / pharmaceutical chemical analysis. The latter
students are typically master students using analytical techniques during the experimental work
for the master thesis. The course focuses both on theoretical and practical aspects of
bioanalysis. The first part of the course teaches the principles of major bioanalytical techniques
at high level (lectures):
• Sample preparation (protein precipitation, liquid extraction, solid-phase extraction)
• Liquid chromatography
• Liquid chromatography-mass spectrometry
• Gas chromatography
• Gas chromatography-mass spectrometry
• Capillary electrophoresis
The second part of the course teaches the use of the above techniques at high level for the
following purposes (lectures):
• Determination of small molecule pharmaceuticals in biological fluids (blood, urine,
saliva, dried blood spots)
• Determination of biopharmaceuticals in biological fluids
• In-vitro metabolism studies of small molecule pharmaceuticals
Application areas include therapeutic drug monitoring, in-vitro metabolism studies,
forensictoxicology, and doping analysis.
The third part of the course focus on reading and understanding research articles in bioanalysis
related to the techniques and applications outlined above, and include student presentation of
selected articles.
The fourth part of the course comprises laboratory exercises related to the techniques and
applications outlined above.
Learning Outcome
At the end of the course, students are expected to be able to:
Knowledge
• Have an in-depth theoretical understanding of the major techniques used in bioanalysis of
pharmaceuticals
• Understand the individual steps in procedures for determination of small molecule
pharmaceuticals and biopharmaceuticals in biological fluids
• Understand the individual steps of in-vitro metabolism studies of small molecule
pharmaceuticals
Skill
• Be able to perform practical bioanalytical work according to published / existing
procedures
• Know and be able to use a broad number of separation and detection principles as well as
sample preparation techniques used for bioanalysis.
• Understand the principles behind and use the analytical chemical instrumentation needed
for high sensitivity analysis of samples of biological origin.
• Judge and use the relevant original analytical chemical literature, handbooks and
databases.
Competence
• Understand and perform bioanalytical chemical work.
• Develop new analytical chemical methods for analysis of samples of biological origin (e.g.
urine, plasma, serum, faeces, saliva, synovial liquid, plant materials etc.).
• Design sampling and storage protocols for in vivo studies of drug substances.
Literature
• Steen Honore Hansen, Stig Pedersen-Bjergaard: Bioanalysis of Pharmaceuticals: Sample
Preparation, Chromatography and Mass Spectrometry, ISBN: 978-1-118-71682-3, Wiley
(2015)
• Additional course materials such as manuals and scientific papers are availabe from the
course homepage
Recommended Academic Qualifications
Course teaching is based upon the assumption that the student has acquired basic skills in
instrumental analytical chemistry corresponding to at least a 7.5 ECTS course at bachelor level. In
addition general knowledge within the areas of organic chemistry, inorganic chemistry, physical
chemistry, analytical chemistry, biochemistry, pharmacology, toxicology, and drug development
at bachelor level is expected.
Teaching and learning methods
Lectures: 32 hours
Laboratory exercises: 24 hours
Feedback form
Oral
Collective
Sign up
Self Service at KUnet
Open for credit transfer students and other external students. Apply here:
Credit transfer students:
http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/
Other external students:
http://healthsciences.ku.dk/education/exchange_guest_students/guest-students/
Credit transfer and other external students are welcomed on the course if there are seats
available and they have the academic qualifications.
Exam (SFKKA9021E- written examination)
Credit
7,5 ECTS
Type of assessment
Written examination, 2 timer under invigilation
Examination type:
2 hour multiple-choice test.
Examination design:
The multiple choice-test is made up of a number of statements (typically 50) to which the student
has to decide whether they are true or false.
Exam registration requirements
In order to be able to take the exam the oral presentation of the "Independent Study Activity"
must be approved and the student must have completed all the laboratory exercises.
Aid
Written aids allowed
There is access to the following at the exam on Peter Bangs Vej:
• Office (Word, Excel, Onenote and Powerpoint)
• IO2 – the digital pen
• Panoramic Viewer
• Paint
• Calculator – Windows' own
• R – Statistical programme
• ITX MC – multiple choice programme
• Adobe reader
• ChemDraw
• MathType formel programme
• Maple
• USB access – for usb stick with notes etc.
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment
To pass the course the student must be able to:
Knowledge
• Have an in-depth theoretical understanding of the major techniques used in bioanalysis of
pharmaceuticals
• Understand the individual steps in procedures for determination of small molecule
pharmaceuticals and biopharmaceuticals in biological fluids
• Understand the individual steps of in-vitro metabolism studies of small molecule
pharmaceuticals
Skill
• Be able to perform practical bioanalytical work according to published / existing
procedures
• Know and be able to use a broad number of separation and detection principles as well as
sample preparation techniques used for bioanalysis.
• Understand the principles behind and use the analytical chemical instrumentation needed
for high sensitivity analysis of samples of biological origin.
• Judge and use the relevant original analytical chemical literature, handbooks and
databases.
Competence
• Understand and perform bioanalytical chemical work.
• Develop new analytical chemical methods for analysis of samples of biological origin (e.g.
urine, plasma, serum, faeces, saliva, synovial liquid, plant materials etc.).
• Design sampling and storage protocols for in vivo studies of drug substances.
Students are evaluated from the participation in the laboratory exercises as well as from the
multiple choice examination and their "Independent Study Activity" where they critically present
analytical chemical literature.
Workload
Category Hours
Lectures 32
Preparation 150
Practical exercises 24
Total 206
Course information
Language
English
Course code
SFKKA9021U
Credit
7,5 ECTS
Level
Full Degree Master
Duration
1 block
Placement
Block 1
Schedule
C
Course capacity
30 students
Continuing and further education Study board
Study Board of Pharmaceutical Sciences
Contracting department
Department of Pharmacy
Course Coordinators
Nickolaj J. Petersen (nickolaj.petersen@sund.ku.dk)
Hovedansvarlig
Stig Pedersen-Bjergaard (s.pedersenbjergaard@sund.ku.dk)
Study secretary: Malthe Sørensen (studieservice-UP2@sund.ku.dk)
Lecturers
Stig Pedersen-Bjergaard (qnr932)
Nickolaj J. Petersen (njl271)
Tam Nguyen (kng128)
Kasper Dyrberg Rand (qvw197)
Saved on the 22-12-2017
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.
Accept af cookies fra ku.dk
Ku.dk bruger blandt andet cookies til at udarbejde statistik
over anvendelsen af sitet.
Du kan altid slette cookies fra ku.dk igen.
Accepter cookies Læs
mere om cookies på ku.dk
Københavns Universitet - Kurser
Advarsel
Denne side er en kladde og bør kun tilgås via linket i kursuskatalogets inddatering. Vi kan
se, du ikke kommer derfra, så der er muligvis sket en fejl. Det link, du sandsynligvis har
brug for, er linket til den offentlige version. Kontakt venligst den person, der har givet dig
linket (eller den redaktør, der har offentliggjort linket), så det kan rettes til den korrekte
offentlige version.
SFKKB9081U Theories and Research Methods in Social and
Clinical Pharmacy Expand all Volume 2018/2019
Education
MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes
cand.scient.pharm and cand.pharm) - elective
MSc Programme in Medicinal Chemistry - elective
MSc Programme in Pharmaceutical Sciences (English programme) - elective
Content
The course covers use of theories and research methods commonly used within the fields of
social and clinical pharmacy. These theories and methods are typically from the social
sciences and are relevant to most areas where pharmacists work.
The course deals with why, how, and when theories and models are used in the social
sciences. It also presents a selection of specific theories and models used in social and
clinical pharmacy. Also epistemology and methodological perspectives are presented, e.g.
consequences of choosing (or not choosing) epistemic and methodological stand-points.
Further, the course includes a general overview of research designs and relevant methods
within social pharmacy and clinical pharmacy. Some methods are taught more in-depth and
students also get to use some of them in a minor field study group assignment. These
methods are:
• Qualitative methods: observations, individual interviews and focus groups
• Quantitative methods: surveys and register-based studies
Learning Outcome
At the end of the course, students are expected to be able to:
Knowledge
• Describe central theories and methods within social and clinical pharmacy
• Explain how theories and research methods are used in social and clinical pharmacy
• Describe the concepts of epistemology and methodology, incl. the consequences of
choosing epistemic and methodological stand-points
Skills
• Critically assess scientific studies within social and clinical pharmacy
• In a group, conduct a minor field study, including research question definition, data
collection and analysis
Competence
• Design, and implement, a minor research project within social and clinical pharmacy,
including applying theory and choosing relevant method(s).
Literature
Robson C. Real World Research. John Wiley and Sons Ltd. 3rd edition or later.
Relevant scientific papers and book chapters
Formal requirements
Non.
Teaching and learning methods
Lectures, seminars, minor field study, individual assignments and group work.
Feedback form
Oral
Collective
Peer feedback (Students give each other feedback)
Sign up
Self Service at KUnet
Open for credit transfer students and other external students. Apply here:
Credit transfer students:
http://healthsciences.ku.dk/education/other-programme-options/credit-transfer-students/
Other external students:
http://healthsciences.ku.dk/education/exchange_guest_students/guest-students/
Exam (SFKKB9081U - continuous assessment)
Credit
7,5 ECTS
Type of assessment
Continuous assessment
Course participation
In order to obtain the course certificate the students should:
- Attend mandatory sessions
- submit individually written assignments, that should be approved prior to the individual oral
examination
- in groups be part of a minor field study, including written and oral presentations
- pass an individual oral examination based on the written group report
Exam registration requirements
Aid
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment
The following elements must be demonstrated to obtain the course certificate:
Knowledge
• Describe central theories and methods within social and clinical pharmacy
• Explain how theories and research methods are used in social and clinical pharmacy
• Describe the concepts of epistemology and methodology, incl. the consequences of
choosing epistemic and methodological stand-points
Skills
• Critically assess scientific studies within social and clinical pharmacy
Competence
• Design a minor research project within social and clinical pharmacy, including applying
theory and choosing relevant method(s)
Workload
Category Hours
Lectures 20
Preparation 104
Seminar 10
Practical exercises 70
Guidance 2
Total 206
Course information
Language
English
22-12-2017
Course code
SFKKB9081U
Credit
7,5 ECTS
Level
Full Degree Master
Duration
1 block
Placement
Block 2
Schedule
A
Course capacity
60 students
Continuing and further education Study board
Study Board of Pharmaceutical Sciences
Contracting department
Department of Pharmacy
Course Coordinators
Lourdes Cantarero Arevalo (lou.cantarero@sund.ku.dk) Sofia
Kälvemark Sporrong (sofia.sporrong@sund.ku.dk)
Saved on the 22-12-2017
Hvis du har spørgsmål til kurset, skal du henvende dig til din lokale studieadministration.