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International Trained-PharmD (ITPD) Foundational Examinations Study Guide All applicants for the ITPD program are required to pass two foundational pharmacy sciences competency exams (one on biomedical sciences and one on pharmaceutical sciences) prior to admission into the ITPD program. These foundational competencies exams will cover the following learning objectives. BASIC BIOMEDICAL SCIENCES Anatomy & Physiology structure and function of Minor body systems: integumentary, muscular skeletal, cardiovascular, lymphatic, respiratory, digestive, nervous, endocrine, urinary, reproductive, and body fluid and electrolytes molecular aspects of cell biology cell physiology and cellular structure and organization Pathology/pathophysiology basic principles and mechanisms of disease including: inflammation & repair, degeneration, disturbances on hemodynamics, developmental defects, neoplasia pathophysiology of disease states amenable to pharmacist intervention Microbiology pathogenic micro-organisms of man Immunology human immunity and immune response principles of antigen-antibody relationships molecular biology of immune response genetic basis for antibody synthesis, development, function, and immunopathology Biochemistry/biotechnology chemistry of biomacromolecules (proteins, lipids, carbohydrates, and DNA) enzymology and co-enzymes and kinetics metabolic pathways to energy utilization nucleic acid metabolism, including DNA replication and repair, RNA, and protein synthesis recombinant DNA technology Molecular biology/genetics cell structure and components ion channels and receptor physiology mitosis and meiosis chromosomes and DNA gene transcription and translation processes recombinant DNA technology Biostatistics understanding of commonly-used statistical tests and their basis management of data sets evaluation of statistical results understanding of statistical versus clinical significance

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International Trained-PharmD (ITPD) Foundational Examinations Study Guide

All applicants for the ITPD program are required to pass two foundational pharmacy sciences competency exams (one on biomedical sciences and one on pharmaceutical sciences) prior to admission into the ITPD program. These foundational competencies exams will cover the following learning objectives.

BASIC BIOMEDICAL SCIENCES Anatomy & Physiology structure and function of Minor body systems: integumentary, muscular skeletal, cardiovascular, lymphatic, respiratory, digestive, nervous, endocrine, urinary, reproductive, and body fluid and electrolytes molecular aspects of cell biology cell physiology and cellular structure and organization Pathology/pathophysiology basic principles and mechanisms of disease including: inflammation & repair, degeneration, disturbances on hemodynamics, developmental defects, neoplasia pathophysiology of disease states amenable to pharmacist intervention Microbiology pathogenic micro-organisms of man Immunology human immunity and immune response principles of antigen-antibody relationships molecular biology of immune response genetic basis for antibody synthesis, development, function, and immunopathology Biochemistry/biotechnology chemistry of biomacromolecules (proteins, lipids, carbohydrates, and DNA) enzymology and co-enzymes and kinetics metabolic pathways to energy utilization nucleic acid metabolism, including DNA replication and repair, RNA, and protein synthesis recombinant DNA technology Molecular biology/genetics cell structure and components ion channels and receptor physiology mitosis and meiosis chromosomes and DNA gene transcription and translation processes recombinant DNA technology Biostatistics understanding of commonly-used statistical tests and their basis management of data sets evaluation of statistical results understanding of statistical versus clinical significance

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PHARMACEUTICAL SCIENCES Medicinal chemistry physico-chemical properties of drug molecules in relation to drug absorption, distribution, metabolism, & excretion chemical basis of pharmacology and therapeutics fundamental pharmacophores for drugs used to treat disease structure activity relationships in relation to drug-target interactions chemical pathways of drug metabolism application to making drug therapy decisions Pharmacology mechanism of action of drugs in various categories role of pharmacology in drug choice and the treatment of disease pharmacodynamics of drug action and absorption, distribution, metabolism, and elimination adverse effects and side effects of drugs drug-target interactions drug-drug, drug-food, drug-lab test interactions drug discovery and development Pharmacognosy & alternative & complemetary med. concepts of crude drugs, semi-purified, and purified natural products variability of occurrence of pharmacologically active substances in plants & impact on regulatory aspects of herbal products Toxicology mechanism of toxicity and toxicokinetics acute and chronic toxic effect of xenobiotics on the body, including drug or chemical overdose and toxic signs of drugs of abuse antidotes and approaches to toxic exposures Pharmaceutics/biopharmaceutics physical-chemical principles of dosage forms biological principles of dosage forms principles of drug delivery via dosage forms (e.g., liquid, solid, semi-solid, controlled release, patches, & implants) principles of dosage form stability and drug degradation in dosage forms materials and methods used in preparation and use of dosage forms Pharmacokinetics/clinical pharmacokinetics basic principles of in vivo drug kinetics (linear and nonlinear) principles of bioavailability/bioequivalence physiologic determinates of drug onset and duration drug, disease, and dietary influences on absorption, distribution, metabolism, and excretion clinical pharmacokinetics of commonly used and low-therapeutic-index drugs the pharmacokinetic-pharmacodynamic interface Extemporaneous compounding/parenteral/enteral United States Pharmacopeia guidance on compounding and FDA Compliance Policy Guidelines techniques and principles used to prepare and dispense individual extemporaneous prescriptions, including dating of compounded dosage forms liquid (parenteral, enteral), solid, semi-solid, and topical preparations dosage form preparation calculations sterile admixture techniques: United States Pharmacopeia (USP) Chapter 797, stability and sterility testing and dating, clean room requirements, infusion devices and catheters

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Suggested Study References:

BASIC BIOMEDICAL SCIENCES • Molecular Biology of the Cell, 4th edition; Bruce Alberts, Alexander Johnson, Julian

Lewis, Martin Raff, Keith Roberts, and Peter Walter. New York: Garland Science; 2002. • The Cell, 2nd edition; A Molecular Approach; Geoffrey M Cooper. Boston University

Sunderland (MA): Sinauer Associates; 2000. • Immunobiology, 5th edition; The Immune System in Health and Disease; Charles A

Janeway, Jr, Paul Travers, Mark Walport, and Mark J Shlomchik. New York: Garland Science; 2001.

• The Biology of Cancer, 7th Edition; Robert A. Weinberg. New York: Garland Science; 2007.

• Lehninger Principles of Biochemistry, by David L. Nelson and Michael M. Cox, Fifth Edition.

• Biochemistry by Jeremy M. Berg, John L. Tymoczko, and Lubert Stryer, Sixth Edition. • Foye’s Principles of Medicinal Chemistry 7th edition. Thomas L. Lemke. Lippincott Williams &

Wilkins; 2012

PHARMACEUTICAL SCIENCES • Bauer, Larry A. Applied Clinical Pharmacokinetics. McGraw-Hill. 2001. • Handbook of Basic Pharmacokinetics, Including Clinical Applications, 7e (Wolfgang

Ritschel, Gregory Kearns) • Basic Physical Pharmacy. 1st edition. Joseph K.H. Ma and Boka W. Hadzija. 2013 • Foye’s Principles of Medicinal Chemistry 7th edition. Thomas L. Lemke. Lippincott

Williams & Wilkins; 2012 • Brunton L L, Blumenthal D K, Murri N, Dandan R H, Knollmann B C. Goodman & Gilman's

The Pharmacological Basis of Therapeutics. 12th ed. New York: McGraw-Hill, 2011

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Learning Objectives : Intro to Immunolgy

Please note: The objectives in this unit are intended to familiarize you with learning

objectives as we use them in this course. Try to answer them now as well as you can, but

don't panic if you think your answers are inadequate; all the material in Unit 1 will be

covered again later in the course. Rest assured that by mid-term time these somewhat

difficult-looking objectives will be easy as pie.

1. Please define: antigen

antigenic determinant

toll-like receptor

pattern-recognition receptor

pathogen-associated molecular pattern

cytokine

chemokine

2. Discuss the role of the innate immune system.

3. Describe how innate immunity can lead to adaptive

immunity, and name the cell that bridges the two systems.

4. Give an example each of how the immune system can be

helpful or harmful to its host.

5. Describe the recognition and effector functions of the

immune system. Distinguish recognizing and effector cells.

6. Discuss the similarities and differences between T cell-

mediated and antibody-mediated immunity.

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7. Describe at least 2 functions of T cells.

8. Describe at least two functions of the complement

system.

9. Define the concept of immunopathology, and give two

examples

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Learning Objectives:

Anatomy and Physiology of the Immune System

1. Define:

leukocytes

mononuclear cells

polymorphonuclear cells

granulocytes

mast cells

plasma and serum

2. Sketch schematically a neutrophil; eosinophil; basophil; small

lymphocyte; lymphoblast; plasma cell; monocyte. Indicate the

characteristic features which distinguish each cell type.

6. Define antigen, and compare it to immunogen. Discuss a

potential uses if any antigen could be made into a tolerogen.

7. Discuss lymphocyte activation by antigen with respect to:

receptor binding, proliferation, differentiation.

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Antibody Structure

1. Define:

H chain

L chain

kappa and lambda chains

hinge region

Fab, F(ab')2, Fc

complementarity-determining region

variable (V) and constant (C) regions

VL and CL

2. Name the 5 antibody classes, and their characteristic heavy

chains.

3. Draw a diagram of the structure of typical molecules of each

class. Label the heavy and light chains; Fc and Fab parts; J chains;

antibody combining sites; main interchain disulfide bonds; secretory

component.

4. Discuss the significance of the fact that in any one antibody

molecule, both H and both L chains are identical.

6. Describe the structure of antibody combining sites.

7. Explain why complementarity-determining regions are also called

hypervariable regions.

8. Give an example of a subclass, an allotpe, an idiotype.

11. Define Fc receptors. Name the inflammatory cells which have

them.

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Learning Objectives: Antibody Specificity, Diversity, Genes:

1. Define: toxoid; DNA recombination; RNA splicing; somatic

hypermutation.

2. Define cross-reactivity. Give an example of a non-self antigen

which cross-reacts with a self antigen. Explain, in terms of

lymphocyte activation, how a self antigen might not itself elicit

antibody, but might react with antibody elicited by a cross-reacting

antigen.

3. Discuss the Clonal Selection Theory.

4. Define allotypic exclusion. Demonstrate your knowledge of the

concept by first stating the number of chromosomes in a cell which

bear H or L genes, and then the number that actually contribute to

a particular B cell's antibody product.

5. Draw a diagram of the heavy and light chain gene regions of

human DNA. Indicate V, D, J and C subregions. Show how a heavy or

light chain gene is assembled out of these subregions during the

differentiation of a B cell.

6. Describe the somatic recombination model which explains how

antibodies of the same specificity (idiotype) can be found in two or

more different classes ("class switching").

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8. Define somatic mutation, and describe the essential difference

between the somatic mutation and germ line hypotheses of

immunological diversity.

9. Describe the mechanisms by which more diversity is created by

nucleotide insertion and removal during V(D)J recombination,

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Learning Objectives: Antibody Function and Complement:

1. Define: valence, affinity, precipitation, agglutination

2. Distinguish the five classes of immunoglobulins in terms of:

a. passage across the placenta

b. ability to activate complement by the classical pathway

c. ability to activate complement by the alternative pathway

d. involvement in allergic diseases

e. “first line of defense”

f. most resistant to enzymatic digestion

6. Compare and contrast precipitation and agglutination in terms of

the nature of the antigens involved, and sensitivity of the tests.

7. Discuss how complement plays roles in both innate and adaptive

immunity.

8. List the components of complement in the order in which they

become activated in the classical pathway. Name those that are also

activated in the alternative pathway.

9. Discuss the lectin-mediated pathway of complement activation.

10. Discuss the different ways in which complement is activated by:

IgG; IgM; IgA; polysaccharides.

11. Identify the complement components which are: opsonizing; lytic;

anaphylatoxic; and chemotactic.

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Learning Objectives: Ontogeny, T and B Cells:

1. Define: stem cell; B cell; T cell; pre-B cell; pre-T cell; self-

tolerance.

4. Describe the sequence of appearance of cytoplasmic and surface

immunoglobulins in developing B cells. Using these data, derive a

model that could explain self-tolerance at the B cell level ("clonal

abortion").

5. Draw a graph showing the antibody response to a typical antigen

in a primary and in a secondary response. Show both IgM and IgG

antibody levels.

6. Draw a graph which shows relative IgG and IgM levels in a normal

infant from conception to one year of age. Distinguish maternal

from infant's antibodies.

7. Given a newborn's antibody titer, interpret its significance if the

antibody is IgG, or IgM. If IgG, calculate what the titer will be at 4

months of age, and state the assumptions you made when you did

the calculation.

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Learning Objectives: T Cells 1 and 2:

1. List the four main types of T cells, and define their functions.

2. Describe the surface markers that can be used to distinguish

between T and B cells in humans.

3. Describe markers that Th1, Th2, and killer T cell (CTL)

subpopulations in humans have on their surfaces.

4. Define lymphokine and cytokine, and give an example of each.

5. Describe an activity of interferon-gamma (IFNã).

6. Define mitogen, and name two T cell mitogens. Name a mitogen

that stimulates both B and T cells in humans.

7. Distinguish between the effects of a mitogen and an antigen when

added to normal blood lymphocytes.

8. Compare and contrast the antigen receptors of T and B cells.

9. Discuss the structures recognized by T cell receptors.

Distinguish between what is recognized by helper and cytotoxic T

cells.

10. Discuss what is meant by "MHC-restriction". Name the classes

of MHC molecules by which CTL, Th1 and Th2 are restricted.

11. Describe the role of T cells in ridding the body of a viral

infection.

12. Describe the characteristics of T-independent antigens.

14. Discuss the mechanism by which T cells help B cells.

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LEARNING OBJECTIVES: Immunity and Vaccines

1. Compare the roles of cell-mediated and humoral immunity in virus

infections with regard to: preventing the infection; controlling

spread of viruses in the body; which is responsible for recovery

from disease; how each can cause immunopathology.

2. Discuss the possible roles of Th1 and CTL in recovery from virus

infection.

3. Define "local immunity" and give an example.

4. Identify those organisms against which cell-mediated immunity is

most effective.

5. Identify those organisms against which humoral immunity is most

effective.

6. Identify the types of organisms against which IgE immunity may

play an important role; discuss possible mechanisms.

7. Describe the mechanism by which trypanosomes in sleeping

sickness evade the host's humoral immune response.

8. Give an example of a human and an animal antitoxin; a toxoid; a

killed virus vaccine; and a live virus vaccine. Identify the one which

produces the longest-lasting immunity. Discuss possible hazards of

each type of preparation.

9. State the appropriate times for immunization of children against

diphtheria, pertussis (whooping cough), tetanus, polio, and measles.

Discuss why live viral vaccines tend to be ineffective in the very

young.

10. Discuss the use of IgG and IgM antibody titers in the diagnosis

of intrauterine and neonatal infections.

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11. Identify the oral and parenteral polio vaccines by the names of

their developers. Discuss their relative advantages and

disadvantages, and note which is currently used in the USA.

12. Discuss the pros and cons and advances in pertussis (whooping

cough) immunization.

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LEARNING OBJECTIVES: Immunohematology

1. For persons of the A, B, AB and O blood groups, give the following

data: most and least common groups; red cell antigens; specificities

of the ABO antibodies in their plasma; safe donors to that type;

safe recipients of blood from that type; possible genotypes.

2. Name the class of most ABO isohemagglutinins.

9. Define heterophile antibody, and identify a common disease in

which one type is increased enough to be useful diagnostically.

10. In Hemolytic Disease of the Newborn, explain:

a. The consequences of severe hemolysis in the newborn.

b. The way in which the mother becomes sensitized.

c. The class of antibody to Rh(D) the mother makes.

d. The consequences of sensitization to subsequent fetuses.

e. The role of Rh-immune globulin.

11. Explain the situation in which ABO hemolytic disease of the

newborn can occur.

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Learning Objectives for Type I Immunopathology

1. Define the following: atopic; immediate hypersensitivity;

allergy, allergen; anaphylaxis; asthma; urticaria, hives, wheal-and-

flare reaction

2. State the approximate incidence of atopic diseases in

the general population, and in individuals with allergic parents.

3. Describe the mechanism of IgE-mediated hypersensitivity in

terms of: IgE attachment to basophils or mast cells; reaction with

allergens; mediator release; effects of mediators on target tissues

and cells.

4. Discuss the features that the various atopic diseases have in

common which justify lumping them together.

5. State the principles of the RAST and basophil degranulation

tests. Compare these tests to intradermal skin tests with

reference to safety and specificity.

6. Discuss specific hyposensitization therapy of allergic disease,

considering duration of effect, risk of anaphylaxis, percent of

patients obtaining significant relief.

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7. Describe the immediate allergic reaction and the late-phase

reaction in terms of:

a. time course of the reaction

b. mediators involved

c. histology

8. Discuss the similarities and differences between anaphylactic

and anaphylactoid reactions.

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Type II Immunopathology: Learning Objectives:

1. Describe the molecular and cellular details of the immunologic

mechanism by which tissue damage occurs in a Type II

("cytotoxic antibody") reaction.

2. Give an example of a Type II mechanism disease of muscle,

kidney, heart, red cells, platelets, lung, thyroid, pancreatic

islets.

3. Describe the fluorescent antibody tests which would allow you

to make the diagnosis of Goodpasture's Syndrome, given:

patient's kidney biopsy; normal kidney biopsy; patient's serum;

and fluoresceinated goat antisera to human IgG and

complement.

4. Distinguish between the "lumpy-bumpy" and linear

immunofluorescent patterns in terms of the most probable

immunopathologies they represent.

5. Describe how autoimmune disease could result from:

A. The innocent bystander phenomenon

B. Cross-reaction of a foreign antigen with self

C. Coupling self antigen with a foreign antigenic "carrier"

D. Physicochemical alteration of self

E. Emergence of a forbidden clone

F. Exposure of a sequestered antigen

G. Failure of suppressor T cells

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6. Identify "Rheumatoid Factor" and describe its molecular

nature.

7. Give an example of a condition in which antibody stimulates

rather than inhibits or harms its target cell.

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Learning Objectives Immunodeficiency:

1. Characterize the infections you would expect in a pure B cell

deficiency; in a pure T cell deficiency.

2. Describe the clinical features which, although not immunological,

are associated with Di George syndrome.

3. Name the enzyme which is absent in some cases of SCID. Discuss

possible approaches to replacing this enzyme.

4. Discuss transplantation therapy in immunodeficiency diseases.

Include a consideration of side effects.

5. Given a child with recurrent infections, describe in principle tests

which could be done to determine if there is a T, B or combined

immunodeficiency, or a PMN, macrophage or complement problem.

6. Describe the contents of commercial gamma globulin and indicate

the conditions in which it can be useful replacement therapy.

Compare and contrast intramuscular and intravenous therapy.

7. Name two viruses which are immunosuppressive in humans.

Discuss a possible mechanism for the immunosuppression caused by

one of these viruses.

8. Describe the immunological problem of the Nude mouse, and name

which immunodeficiency condition it resembles.

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9. Name the enzyme which is absent in some cases of SCID. Discuss

possible approaches to replacing this enzyme.

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Learning Objectives Type III Immunopathology:

1. Arthus reaction and serum sickness are local and general

manifestations of immune complex disease; describe the mechanism

of tissue damage. Discuss why this is sometimes called "innocent

bystander injury".

2. Indicate the critical size at which immune complexes get stuck in

basement membranes.

3. Describe "one-shot" serum sickness.

4. Discuss the, types of tissues in which damage is most likely to

occur from deposition of immune complexes.

5. Discuss the immunological mechanism of a typical Type III

disease involving exogenous antigen.

6. Discuss how urticaria could result from interaction of antigen

with either IgE or IgG antibody.

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Learning Objectives Type IV Immunopathology

1. Describe the sensitization (immunization) process in cell-mediated

immunity (CMI), in terms of: antigen association with macrophages;

sites of T cell proliferation; time involved.

3. Describe the mechanism of contact hypersensitivity; give

examples of common sensitizers.

4. Distinguish between resting and "angry" (activated) macrophages.

5. Describe how delayed hypersensitivity can be passively

transferred to another individual. Discuss how this maneuver can be

used to show that delayed hypersensitivity is a T cell-mediated

reaction. Discuss problems in the transfer of delayed

hypersensitivity in humans.

6. Describe an in vitro test by which one can determine if a patient

has cell-mediated immunity (delayed hypersensitivity) to a

particular antigen.

7. Distinguish between specific and generalized anergy.

8. Describe the differences between first-set, second-set and

hyperacute allograft rejection. Outline the mechanisms involved in

each case.

10. Describe immune deviation in cellular and cytokine terms.

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Immunodiagnosis

Learning Objectives:

1. Describe the procedure used in serum protein electrophoresis, and the

underlying principles.

2. Discuss the serum protein electrophoretic pattern which would be

expected if a patient:

a. was normal

b. had selective IgA deficiency

c. had multiple myeloma

d. had severe pyogenic (high-grade bacterial) infections

e. was hypogammaglobulinemic

3. Discuss single radial immunodiffusion, with regard to the types of

antigens that can be quantitated with it, and the way that quantitation

is done

4. Outline the principles involved in nephelometry. Compare to single

radial immunodiffusion for cost and speed.

5. Describe a test that is used for determining if a patient has antibody

to a soluble or particulate antigen.

6. Describe in principle the ELISA and RIA tests. Discuss the types of

antigens that can be measured in these tests. Diagram the reactants

involved when the ELISA is used to measure antibody, and to measure

antigen.

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7. Describe a test which can be used to evaluate T cell

immunocompetence in a clinic or on the ward.

8. Describe tests to evaluate T cell numbers and function in the lab.

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LEARNING OBJECTIVES: HIV AIDS

1. Explain the difference between "HIV-seropositive" and "AIDS".

2. Name the virus that causes AIDS, and its classification.

3. Discuss the origin of the AIDS virus and the origins of the

current epidemic.

4. Identify the approximate number of cases in the U.S. and in the

world, and discuss the rate of change in incidence.

5. Discuss the pathogenesis of AIDS, including target cell types,

mode of entry of the virus into a cell mode of exit, latency versus

productive infection.

6. Distinguish between the roles of Th1 and Th2 in the progression

of HIV infections.

7. Discuss the types of infections seen in AIDS patients, and

provide an immunological basis for this spectrum.

8. Discuss possible reasons for which the total number of CD4 cells

in AIDS patients decline.

9. Discuss reasons for which antibody seems to be ineffective in

HIV infection.

10. Describe the laboratory diagnosis of AIDS.

11. Discuss risk groups and risky behavior in AIDS.

12. Discuss the prospects and problems of AIDS vaccine

development.

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Learning Objectives Tumor Immunology:

1. State the concept of the Immune Surveillance theory. Show

how data from immunosuppressed and immunodeficient patients

support the theory. In light of this theory, discuss the failure of

nude mice to spontaneously develop cancer.

2. Describe the difference between virally-induced and

chemically- induced tumors in terms of antigenic cross-reactivity.

3. Compare and contrast:

Tumor-associated antigens (TAA)

Tumor-specific transplantation antigens (TSTA)

4. Define carcinoembryonic antigen (CEA) and discuss its

usefulness in screening for, diagnosis and follow-up of bowel cancer.

5. Describe these mechanisms by which the body may kill tumor

cells:

a. Antibody / complement-mediated lysis

b. Antibody/ opsonization

c. ADCC

d. Killer T cells (CTL)

e. Th1 and angry macrophages

f. Lymphotoxin

g. Natural killer (NK) cells

6. In the context of the above list of mechanisms, discuss the low

incidence of spontaneous tumors in nude mice and Di George

syndrome patients.

8. Define tumor immunotherapy.

9. Describe two mechanisms by which BCG treatment may cause

tumor regression.

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10. Discuss prospects and problems concerning the use of

monoclonal antibodies in the diagnosis or treatment of cancer (see

also Unit 20).

11. List actions of interferons that might be important in the

response to tumors.

12. Describe the nature and use of lymphokine-activated killer cells.

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LEARNING OBJECTIVES: Immune malignancies/New Directions

1. Identify a malignant condition in which the cells involved

resemble:

A. null cells

B. activated T cells

C. resting B cells

D. activated B cells

E. activated B cells secreting IgM

2. Discuss the events thought to be necessary for the development

of Burkitt's lymphoma, including: the virus involved, the nature of

the chromosomal translocation, the role of malarial infection.

3. Describe an experiment that shows that immune responses might

be "conditioned" in a Pavlovian sense.

4. Describe in principle the procedure for making a monoclonal

antibody. Discuss advantages and disadvantages compared to a

conventional antiserum.

5. Describe in principle the way in which a person could be induced

to make an auto-anti-idiotypic response. Suggest a use for such a

procedure.

6. Define superantigens, and show diagrammatically how they work

to stimulate T cells.