DSA 1 - Drug Development and Safety

Question 1

What is the equation for therapeutic index?

Answer 1

TILE: TI = LD/ED

Question 2

What does it mean if the TI is high?

Answer 2

Drug is safer.

Question 3

What does Phase 1 of a clinical study include?

Answer 3

Healthy volunteers, small numbers (10), safety, and pharmacokinetics.

Question 4

What does Phase 2 of a clinical study include?

Answer 4

Small group of patients (100), efficacy, safety, and dose determination.

Question 5

What does Phase 3 of a clinical study include?

Answer 5

Compares safety with efficacy; large group of patients (1000); and randomized, double-blind, placebo controlled, and crossover studies.

Question 6

What does Phase 4 of a clinical study include?

Answer 6

General large patient population, FDA adverse event reporting system, and detecting drug reactions.

Question 7

What drugs are included in Category A of Pregnancy Safety categories?

Answer 7

Folic acid and Multivitamins

Question 8

What drugs are included in Category B of Pregnancy Safety categories?

Answer 8

Zidovudine and Acetaminophen

Question 9

What drugs are included in Category C of Pregnancy Safety categories?

Answer 9

Aspirin and Fluoroquinolones

Question 10

What drugs are included in Category D of Pregnancy Safety categories?

Answer 10

ACE inhibitors, Tetracyclines, and Antineoplastics

Question 11

What drugs are included in Category X of Pregnancy Safety categories?

Answer 11

Isotretinoin, Thalidomide, Statins, and Oral contraceptives

Question 12

What are some examples of Type I Hypersensitivity Reactions?

Answer 12

Immediate Hypersensitivity (IgE mediated)

Urticaria (Hives), Atopic dermatitis, and Anaphylactic Shock

Question 13

What are some examples of Type II Hypersensitivity Reactions?

Answer 13

Cytosolic Reactions (IgG and IgM mediated)

Hemolytic anemia, Thrombocytopenia, and Drug Induced Lupes Erythematous

Question 14

What are some examples of Type III Hypersensitivity Reactions?

Answer 14

Immune Complexes (Deposition of antigen-antibody complexes in vascular endothelium, leading to inflammation)

Steven-Johnson Syndrome

Question 15

What are some examples of Type IV Hypersensitivity Reactions?

Answer 15

Delayed Hypersensitivity (Sensitized Lymphocytes)

Ampicillin induced skin rash.

Question 16

What occurs with CYP2D6 gene polymorphism?

Answer 16

Poor metabolization of Tamoxifen, leading to relapse in patients with breast cancer due to decreased effects of endoxifen, the active metabolite.

Question 17

What occurs with CYP2C19*17 allele?

Answer 17

Exhibit higher metabolic activation for tamoxifen.