Deck 4: Drug Development and Safety

Question 1

If a generic version of a drug is approved for marketing on the basis of a study comparing the oral bioavailability of the generic and brand name product, which term is associated with the review of this product by the Food and Drug Administration?

A) Harris-Kefauver amendment
B) accelerated drug approval
C) orphan drug amendment
D) abbreviated new drug application
E) investigational new drug

Answer 1

abbreviated new drug application

Question 2

Which term most accurately applies to a study involving the sequential administration of active drug and placebo to all subjects?

A) double-blind study
B) crossover study
C) Phase 1 study
D) postmarketing study
E) preclinical study

Answer 2

crossover study

Question 3

After receiving a sulfonamide compound for a urinary tract infection, a woman develops a life-threatening immune vasculitis known as the Stevens-Johnson syndrome.Which mechanism is usually responsible for this condition?

A) IgE-mediated release of histamine from mast cells and basophils
B) formation of sensitized lymphocytes
C) complement-mediated cell lysis
D) delayed hypersensitivity reactions
E) deposition of immune complexes in blood vessel walls

Answer 3

deposition of immune complexes in blood vessel walls

Question 4

The Food and Drug Administration removed a drug product from the market because it contained a toxic contaminant.Which term is used to describe this type of product in the Food, Drug and Cosmetic Act?

A) misbranded
B) mislabeled
C) adulterated
D) off-label
E) teratogenic