School of Pharmacy Devi Ahilya Vishwavidyalaya, Indore ... plan_eighth sem.pdf · Devi Ahilya...

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School of Pharmacy Devi Ahilya Vishwavidyalaya, Indore

DETAILED COURSE PLAN

A. Subject Specification [1]. Subject title and code: Pharmacology- IV (801-T) [2]. Program(s) in which the Subject is offered: B. Pharm

(If general elective available in many programs indicate this rather than list programs) [3]. Name of faculty member responsible for the Subject : Mr. Manoj Rathore

Mr. Jitendra Sainy [4]. Level/year at which this Subject is offered : Final Year

B. Objectives

[1]. Objective of the Subject: The objective is to understand the various principles of clinical pharmacology. At the end of the course, the student shall have acquired proper knowledge of various

drugs, dosage regimen, adverse effects of the drugs, drug contraindications. Pharmacokinetics and pharmacodynamics of drugs & drug interactions To understand principles of toxicology of various drugs.

C. Subject Description S.No. Topic/ unit No. of lectures

required (i) Principles of Clinical Pharmacology: Dose individualization, Clinical

pharmacokinetics, influence of disease on pharmacokinetics and pharmacodynamics, Population, pharmacokinetics.

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(ii) Drugs used during infancy, neonates, in the elderly persons and their bio-pharmaceutics.

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(iii) Drugs used during pregnancy and drug induced diseases. 5 (iv) The principles, mechanism and clinical evaluation of drug interactions. 5 (v) Common clinical laboratory tests and their interpretation. 5 (vi) General principles of Clinical toxicology. 5 (vii) Therapeutic Drug Monitoring, Concept of Essential Drugs and Rational

Drug use. 5

(viii) Principles of Toxicology: Definition of poison, general principles of treatment of poisoning with particular reference to barbiturates, opioids, organophosphorous and atropine poisoning, Heavy metals and heavy metal antagonists.

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Total lectures 42

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[1]. Subject Components (total contact hours):

Lecture: 4 hrs. per week Practical: No practicals Other: -

[2]. Development of Learning Outcomes in Domains of Learning

i. Description of the knowledge to be acquired: • To understand the fundamental scientific principles of drug action and the various mechanisms by which drugs can mediate their pharmacological effect • To understand the biochemical reactions that result in the metabolism of drugs within the body • To understand the rationale behind designing different dosing regimens of particular drugs in specific patient populations • To understand how specific patient characteristics and genetics can affect the response to a particular class of drugs

To understand various principles of toxicology and poisoning To understand clinical pharmacokinetics and evaluation of drugs.

ii. Teaching strategies to be used to develop that knowledge: Black board teaching, Power point presentation, Overhead projector, Group discussion, Assignments.

D. Learning Resources i. Essential References, Required Text(s), Electronic Materials, Web Sites, Other

learning material such as computer-based programs/CD, professional standards/regulations:

1. Atkinsons, J. A., Principles of Clinical Pharmacology, Elsevier, Academic press, USA. 2. Reid, J., Rubin C. P., Lecture notes on Clinical Pharmacology, Blackwell science, New York. 3. Herfindal, E.T. and Hirschman, J.L., Clinical Pharmacy and Therapeutics, William and Wilkins, Baltimore. 4. Katzung, B.G., Basic and Clinical Pharmacology, The McGraw Hill Companies, USA. 5. Laurence, D.R. and Bennet, P.N., Clinical Pharmacology, Churchill, Livingstone. 6. Parthasarthi, G., Nyfort-Hansen, K., Nahata, M.C., A Textbook of Clinical Pharmacy Practice-Essential Concepts and Skills, Orient Longman. 7. Dipiro, J.T. (Ed.), Pharmacotherapy. A Pathophysiologic Approach, Appleton and Longe, Stanford, Connecticut.

Web resources. www.google.com www.wikipidea.com www.expertconsultbook.com www.emedicinehealth.com www.jfmed.com www.webmd.com

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E. Facilities Required

Indicate requirements for the Subject including size of classrooms and laboratories (i.e number of seats in classrooms and laboratories, extent of computer access etc.)

[1]. Accommodation (Lecture rooms, laboratories, etc.): 1 lecture room and 1 laboratory [2]. Computing resources: -- [3]. Other resources (specify --eg. If specific laboratory equipment is required, list

requirements or attach list): No practicals in syllabus

F. Subject Evaluation and Improvement Processes [1]. Strategies for Obtaining Student Feedback on Effectiveness of Teaching: Feedbacks from the students are taken twice in a semester. [2]. Other Strategies for Evaluation of Teaching The system exists for class test followed by 2 sessional examinations per semester for evaluation of teaching.

G. List of Assignments:

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Devi Ahilya Vishwavidyalaya, Indore School of Pharmacy

COURSE PLAN

A. Subject Specification

Subject and code Pharmaceutical Industrial Management and Accountancy,

802 T

Nature of Subject Compulsory

Course and Semester B.Pharm., Eighth Semester

Faculty Dr. Rajesh Sharma

B. Objectives

The objective of this subject is to develop an understanding of

Different functions of management, concepts, theories and techniques implemented by

Pharmaceutical Industry.

Basic concepts, theories and techniques of economics, labor welfare, insurance and

import and export that contribute to business decision making and development of

analytical skills.

Relevant accounting concepts and techniques in order to facilitate managerial decision

making.

C. Subject Description

Unit Topic No. of Classes

01 Concept of Management: Administrative Management (Planning, Organizing, Staffing, Directing and Controlling), Entrepreneurship development, Operative Management (Personnel, Materials, Production, Financial, Marketing, Time/space, Margin/Morale), Principles of Management (Co-Ordination, Communication, Motivation, Decision-making, Leadership, Innovation, Creativity, Delegation of Authority/Responsibility, Record Keeping), Identification of Key Points to give maximum thrust for development and perfection.

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02 Economics: Principles of economics with special reference to the laws of demand and supply, demand schedule, demand curves, labor welfare, general principles of insurance and inland and foreign trade, procedure of exporting and importing goods.

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03 Materials Management: A brief exposure or basic principles of materials management-major areas, scope, purchase, stores, inventory control, an evaluation of material management.

04

04 Production Management: A brief exposure of the different aspects or Production, Management-Visible and Invisible inputs, Methodology of Activities, Performance Evaluation Technique, Process-Flow, Process Know-how, Maintenance Management.

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05 Accountancy: Principles of Accountancy, Ledger posting and book entries, preparation of trial balance, columns of a cash book, bank reconciliation statement, rectification of errors, Profits and loss account, balance sheet, purchase, keeping and pricing of stocks, treatment of cheques, bills of exchange, promissory notes and Hundies, documentary bills.

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Total No. of Classes 42

Subject Components:

Lecture: 4 hrs. /week Practical: - Other: -

Learning Outcomes

Working knowledge of Different concept, theories and techniques of Management required in Pharmaceutical Industry.

Working knowledge of basic concept of economics, insurance, import export of Pharmaceuticals.

Working knowledge of basic concepts of accountancy. Teaching strategies to be used to develop that knowledge:

Power point presentation, Chalk and talk, interactive discussion, assignments and case study.

D. Learning Resources

1. Stoner, J. A., Freeman, R.E. &. Gilbert, D. R, Management, Prentice Hall, New De1hi.

2. Kotler, P., Marketing Management analysis, planning, implementation & control,

Prentice Hall, Delhi.

3. Smith, H. A., Principles and Method of Pharmacy Management, Lea & Febiger,

Philadelphia.

4. Gopalkrishan, P. and Sundaresan, M., Material management: An integrated approach

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Prentice Hall, New Delhi.

5. Mannoria, C. B, Personal management, Himalaya Publishing House, Bombay.

6. Lachman, L., Lieberman, H.A. and Kanig, J.L., The Theory and Practice of Industrial

Pharmacy, Varghese Publishing House, Mumbai.

7. Kotler, P., Principles of marketing, Prentice Hall, New Delhi.

8. Ali, M. and Gupta J., Drug store and business management, CBS publisher and

distributors New Delhi.

9. Burande, M.D., Principles and practice of drug store administration, Nirali Prakashan,

Pune.


Class room, Computer with power point presentation facility.

F. Subject Evaluation and Improvement Processes

Strategies for Obtaining Student Feedback on Effectiveness of Teaching:

Feedbacks from the students after the completion of First sessional, second sessional. If

required remedial classes will be organized for slow learners.

G. Other Strategies for Evaluation of Teaching

As per existing ordinance two Sessional examinations and end semester examination are

conducted.

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A. Subject Specification [1]. Subject title and code: Pharmaceutical analysis VI (Quality Assurance) (803T) [2]. Program(s) in which the Subject is offered: B. Pharm

(If general elective available in many programs indicate this rather than list programs) [3]. Name of faculty member responsible for the Subject : Dr. Nidhi Dubey [4]. Level/year at which this Subject is offered : Final Year

B. Objectives

Objective of the Subject: The objective is to understand Pharma regulatory systems for quality managements. To understand critical quality parameters from raw materials to finished products and

methods of evaluation of this parameters. To understand development of documentation system for pharmaceuticals. To understand development of new analytical method and regulatory requirement in

method development. At the end of the course, the student shall have acquired the competency in the quality

management of pharmaceutical and its regulatory control.

C. Subject Description Sr. No

Topics to be covered No. of Classes required

1. Orientation class 1 2. Induction class-Introduction to the subject 1 3. Difference between concept of QA and QC 1 4. Concept of TQM 1 5. Tools of TQM 1 6. Development of new analytical method 2 7. GLP-Introduction, regulatory requirements 1 8. USFDA and OECD guideline for GLP 2 9. Culture and concept of GMP 2 10. Part I of Schedule M 4 11. Part I A-E Schedule M 2 12. Comparison of WHO, USFDA and other guidelines 2 13. Introduction to sources of quality variation 1 14. Control of raw materials, equipments and manufacturing process 2 15. Concept of validation 2 16. Approaches to validation 2 17. Organization for validation etc. 1

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18. Equipment validation with example 2 19. What is Patent? Types of patent, procedure for patent application 2 20. Objectives , regulatory significance, types and format of Ph

documentation 2

21. Documents for new drug approval and export registration 2 22. Sampling, sampling procedure and tools, significance 1 23. Sampling plans, and operating characteristics curves 1 24. Interpretation of analytical data 1 25. Concluding class 1


Lecture: 4 hrs. per week Practical: 6 hrs. per week Other: Remedial class, Advance learner class and tutorials.

[2]. Development of Learning Outcomes in Domains of Learning

i. Description of the knowledge to be acquired: Study of all regulatory guideline pertaining to manufacturing, IPR, and analytical method

development. Study of documentation system in Pharmaceutical manufacturing unit. Study concept of quality management system.

ii. Teaching strategies to be used to develop that knowledge: Black board teaching, Power point presentation, Overhead projector, Group discussion, Assignments.



Quality Assurance Guide, The Organization of Pharmaceutical Producers of India, Mumbai.

Nash, R.A. and Walker, A.H., Pharmaceutical Process Validation, Marcel Dekker Inc., New York

Malik, V., Drugs and Cosmetic Act, 1940, Eastern Book Company, Lucknow. Willing, S. H., IV, Good Manufacturing Practices for Pharmaceuticals, Marcel Dekker

Inc., New York. Gennaro, A.R., Remington: The Science and Practice of Pharmacy, Lippincott

Williams and Wilkins, Philadelphia

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Indicate requirements for the Subject including size of classrooms and laboratories (i.e number of seats in classrooms and laboratories, extent of computer access etc.)

[1]. Accommodation (Lecture rooms, laboratories, etc.): 1 lecture room and 1 laboratory [2]. Computing resources: -- [3]. Other resources (specify --eg. If specific laboratory equipment is required, list

requirements or attach list): UV spectrophotometer, IR spectrophotometer, dissolution test apparatus, disintegration test apparatus, friability tester, HPLC instrument etc.

F. Subject Evaluation and Improvement Processes [1]. Strategies for Obtaining Student Feedback on Effectiveness of Teaching: Feedbacks from the students are taken twice in a semester and necessary action is taken accordingly. [2]. Other Strategies for Evaluation of Teaching The system exists for class test(quiz) followed by 2 sessional examinations per semester for evaluation of teaching.

G. List of Assignments: [1]. Flow chart of New Drug Approval process. [2]. Flow chart of analytical method validation parameters.

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A. Subject Specification [1]. Subject title and code: Drug Design (804 T/1) [2]. Program(s) in which the Subject is offered: B. Pharm.

(If general elective available in many programs indicate this rather than list programs) [3]. Nature of the subject: Elective [4]. Name of faculty member responsible for the Subject : Ms. Tamanna Narsinghani [5]. Level/year at which this Subject is offered: Final Year (VIII Sem.)

B. Objectives

[1]. Objective of the Subject:

The objective of this course is to let students understand the process of drug design and development and to study different approaches for Drug Design and their methodologies.

At the end of the course, the student will be able to understand the process of drug design and apply various approaches of drug design.


[1]. Subject Detail S.No. Topic No. of

Classes 1.

Drug Discovery, Design and Development: Introduction to drug design and development, stages of drug design and development, finding a lead, optimizing target interactions, optimizing access to target.

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2.

Quantum Mechanics and Molecular Dynamics: Introduction to quantum mechanics, Postulates of quantum mechanics, electronic structure, AB initio, semi-empirical, density functional and molecular orbital theories. Introduction to molecular mechanisms, Vander Waal interaction, electrostatic interaction, force field and energy minimization. Introduction to Molecular Dynamics, Conformational searching, Systematic search and applications.

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3.

Ligand Based Drug Design: Introduction to QSAR, lead molecule, linear and nonlinear modeled QSAR equations, statistics used in QSAR, physicochemical parameter and molecular descriptors, Hansch approach, Fujita-Ban approach, Hybrid QSAR, Graph Theory, Topological QSAR, 3D-QSAR, MSA, RSA, CoMFA, CoMSIA, Pharmacophore mapping and applications of QSAR in drug discovery, Case study: Tubulin polymerization inhibitors

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4. Structure Based Drug Design: Methods to derive 3D structures, X-ray 10

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crystallography and NMR spectroscopy, pharmacophores, molecular docking, De novo design, Free energies and salvation, electrostatic and non-electrostatic contribution to free energies, 3D data base searching and virtual screening, molecular similarity and similarity searching, combinatorial libraries – generation and utility and further applications on the design of new molecule, Case study: Thymidylate synthase inhibitors and HIV protease inhibitors.

5.

Comparative Protein Modeling: Modeling by Homology-the alignment, construction of frame work, selecting variable regions, side chain placement and refinement, validation of protein models–Ramchandran plot, threading and AB initio modeling, Case study: p38 kinase.

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Total No. of Classes 40 [3]. Subject Components (total contact hours): Lecture: 4 hrs. per week Practical: -- Other: -

[4]. Development of Learning Outcomes in Domains of Learning i. Description of the knowledge to be acquired:

Study and apply different approaches of drug design. Study different approaches with the help of case studies.

ii. Teaching strategies to be used to develop that knowledge: Black board teaching, Power point presentation, Overhead projector, Group discussion, Assignments, Exercises on QSAR studies, Case studies


i. Essential References, Required Text(s), Electronic Materials, Web Sites, Other learning material such as computer-based programs/CD, professional standards/regulations: Books:

Leach, A. R., Molecular Modeling: Principles and Applications, Addison Wesley Longman, Essex, England.

Höltje, H-D, Sippl, W., Rognan, D., Folkers, G., Molecular Modeling, Wiley-VCH, New York.

Cohen, N. R. (Ed.), Guidebook on Molecular Modeling in Drug Design, Academic Press, San Diego.

Grant, G.H., Richards, W.G., Computational Chemistry, Oxford University Press, USA.

Silverman R.B., The Organic Chemistry of Drug Design and Drug Action, Academic Press, New York.

Smith, H.J. Williams H, Eds, Introduction to the Principles of Drug Design, Wright, Boston.

Martin Y.C., Quantitative Drug Design, Dekker, New York. Ariens E.J., Drug Design, Academic Press New York. Perun, T.J. and Propst, C.L., Computer Aided Drug Design, Academic Press, New

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York. Patrick, G., An Introduction to Medicinal Chemistry, Scientific Distributors,

Mumbai. E. Facilities Required

Indicate requirements for the Subject including size of classrooms and laboratories (i.e number of seats in classrooms and laboratories, extent of computer access etc.) [1]. Accommodation (Lecture rooms, laboratories, etc.): 1 lecture room and 1 Computer-

Aided Drug Design (CADD) lab [2]. Computing resources: Computer, Molecular Modeling softwares [3]. Other resources (specify --eg. If specific laboratory equipment is required, list

requirements or attach list): --

F. Subject Evaluation and Improvement Processes [1]. Strategies for Obtaining Student Feedback on Effectiveness of Teaching:

Feedbacks from the students are taken twice in a semester. [2]. Other Strategies for Evaluation of Teaching

The system exists for class test followed by 2 sessional examinations per semester for evaluation of teaching.

G. List of Assignments: [1]. Perform QSAR on the given series. [2]. Enlist various Ligand Based Drug Design techniques and detail them. [3]. Prepare a detailed list of drugs developed using the concept of Drug Design.

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A. Subject Specification [1]. Subject title and code:Food Science Technology (Elective)(804T) [2]. Program(s) in which the Subject is offered: B. Pharm [3]. Name of faculty member responsible for the Subject :Dr. Mrs. Anupama A. Parate [4]. Level/year at which this Subject is offered :Final (IV) Year

B. Objectives

[1]. Objective of the Subject: The course is designed with a prime objective of providing a combination of scientific understanding with knowledge of its application at industrial level; meet the need of the food industries.


[1]. Subject Details

S. No. Topic

Number of lectures allotted

1.

Food Chemistry: Food quality characteristics. Composition and nutritive value of common foods, structure. Properties and metabolic function of food constituents like water. Carbohydrates, lipids, proteins, enzymes, vitamins, minerals,

pigments, colors. Flavoring substances. Undesirable constituents in food. Changes in food constituents during processing and storage.

08

2.

Food Microbiology: Microbial groupings and identification. Nutrient requirements for bacterial culture. Growth and inactivation kinetics, Harmful and beneficial effects of

microbes. Microbes in food industry, Food spoilage, poisoning and

intoxication.

08

3. Food Process Principles:

Basic principles and techniques of food preservation and processing.

08

4. Food Technology: Technological process for industrial manufacture of 08

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selected foods of commercial importance like Jelly Pickles Carbonated beverages Fruit beverages Bakery and Confectionary products Dairy products

5.

Food laws and standards: Food additives, Food packaging, Quality control in food industry.

08

Total 40


Lecture: 4 hrs. per week Practical: -- Other: - [2]. Development of Learning Outcomes in Domains of Learning

i. Description of the knowledge to be acquired: The general objective Food Science technology is to provide a multidisciplinary and

specialised professional training.

The study of this elective subject will result in developing personnel with the necessary

technological and managerial knowledge, skills, and attitudes, which are required to

successfully contribute to solving problems related to food industry.

To accommodate the useful application of knowledge to the developmental needs of

the food industry.

ii. Teaching strategies to be used to develop that knowledge: Black board teaching, Overhead projector, Group discussion, Assignments.



Norton, T., Nick Holden (Eds.), Sustainable Food Processing, Blackwell Publishing,

New York.

Shaw, I., Food Safety: The Science of Keeping Food Safe, Blackwell Publishing, New

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York.

Schuck, P., Dolivet, A., Jeantet, R., Analytical Methods for Food and Dairy Powders

Blackwell Publishing, New York.

Ahmed, J., Rahman, M. (Ed.), Handbook of Food Process Design, Blackwell

Publishing, New York.

Coles, R., Kirwan , M. (Eds.), Food and Beverage Packaging Technology, Blackwell

Publishing, New York.

Earle, R.L., Earle, M.D., Unit Operations in Food Processing, Web Edition, The New

Zealand Institute of Food Science & Technology (Inc.).

Frazier, W.C., Westhoff, C.D., Food Microbiology, Tata Mc Graw Hill Publishing

Company Limited, New Delhi.


Indicate requirements for the Subject including size of classrooms and laboratories (i.e number of seats in classrooms and laboratories, extent of computer access etc.) [1]. Accommodation (Lecture rooms, laboratories, etc.): 1 lecture room [2]. Computing resources: -- [3]. Other resources (specify - eg. If specific laboratory equipment is required, list

requirements or attach list): -

F. Subject Evaluation and Improvement Processes [1]. Strategies for Obtaining Student Feedback on Effectiveness of Teaching:

Feedbacks from the students are taken twice in a semester. [2]. Other Strategies for Evaluation of Teaching

The system exists for class test followed by 2 sessional examinations per semester for evaluation of teaching.

G. List of Assignments: [1]. Basic fundamentals of Carbohydrates, lipids, proteins, enzymes, vitamins, minerals. [2]. Account on use of preservatives.

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Devi Ahilya Vishwavidyalaya, Indore

School of Pharmacy

COURSE PLAN

A. Subject Specification

Subject and code Marketing Management, 804 T/2

Nature of Subject Elective

Course and Semester B.Pharm., Eighth Semester

Faculty Dr. Rajesh Sharma

B. Objectives

The objective of this subject is to develop an understanding of marketing concepts and techniques and the application of the same in the pharmaceutical industry.


Unit Topic No. of Classes

01 Introduction to Pharmaceutical Marketing Management

01

02 Marketing Task: Demand States & Marketing task, Scope of Marketing and Different Markets

03

03 Concept of Marketing: Definition of marketing, Distinction between marketing & Selling, Core Marketing Concept, Marketing Place, Marketing Space, Target Market, Segmentation of Market, Needs, Wants & Demands, Product offering, value & satisfaction, Relationship net work, Supply chain competition, Marketing environment, marketing mix (4 P Components), Other concept’s name under marketing activities.

06

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04 Marketing Opportunities Market Oriented Strategic Planning: SWOT Analysis, Strategic Formulation and Product Planning. Gathering Information and Measuring Demand: MIS, Market Research, Behavioral Research, Marketing Research, Forecasting & Demand Measurement. Analyzing Consumer Markets & Buyer Behavior: Influencing Buyer Behavior, Buying Decision Process, Motivation of Physician towards Brand. Dealing With The Competition - Identifying Competitors, Analyzing Competitors, Strategies, Strength & Weakness, Designing Competitive Strategies.

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05 Developing Market Strategies & Marketing Mix, Product Strategy, Positioning & Differentiating the Market Offering (Product): Positioning to Promote Product Life Cycle Marketing Strategies. New Market Offering: Which markets to Enter, How to Enter the Market, Product Development, Market Testing. Setting the Product Strategy: Product & Product Mix, Product Line Analysis, Brand Decision, Packaging & Labeling.

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06 Managing & Delivering Marketing Programs, Value Net-Work & Marketing Channels: Channel Functions, Channel Levels, Channel Management, Decisions, Selecting, Training, Motivating & Evaluating Channels Members, Channel Dynamics, Conflicts, Co- Operation & Competitions. Managing Retailing, Wholesaling & Market Logistics: Types of Retailing, Types of Wholesaling. Managing Advertising, Sales Promotion & Public Relations: Advertising Objective, Choosing the Advertising Message, Measuring Effectiveness of Advertisement, Sales Promotion & Purpose, Public Relations. Managing Sales Force: Recruitment & Selecting Representative, Training Sales Representative, Supervising, Norms for Customer Calls, Motivating Sales Representative, Evaluating Sales Representative.

10

Total No. of Classes 40

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Subject Components (total contact hours):

Lecture: 4 hrs./week Practical: - Other: -

Learning Outcomes

Working knowledge of different concept, theories and techniques of Pharmaceutical marketing and will provide significant help the students who wish to opt Pharmaceutical marketing as a career.


1. Kotler, P., Marketing Management Analysis, Planning, Implementation & Control, Prentice Hall, Delhi.

2. Smith, H. A., Principles and Method of Pharmacy Management, Lea & Febiger, Philadelphia.

3. Kotler, P., Principles of Marketing, Prentice Hall, New Delhi.

4. Smith, M., Principles of Pharmaceutical Marketing, Lea & Febiger, Philadelphia.

5. Smith, M. Pharmaceutical Marketing: Strategy and Cases, The Haworth Press Inc., Bringhamton, New York.

6. Mehrotra, M., Essentials of Pharmaceutical Sales Management, Cambridge University Press India Pvt. Ltd., New Delhi.


Lecture room, Computer with Projector

F. Subject Evaluation and Improvement Processes

Strategies for Obtaining Student Feedback on Effectiveness of Teaching:

Feedbacks from the students after the completion of First sessional, second sessional. If

required remedial classes will be organized for slow learners.

G. Other Strategies for Evaluation of Teaching

As per existing ordinance two Sessional examinations and end semester examination are

conducted.

School of Pharmacy Devi Ahilya Vishwavidyalaya, Indore ... plan_eighth sem.pdf · Devi Ahilya...

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