Brenner: Pharmacology, 4th Edition

Chapter 04: Drug Development and Safety

Test Bank

Multiple Choice

1. 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

ANS: B. crossover study

2. 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?

Copyright © 2013, 2010, 2006, 2000 by Saunders, an imprint of Elsevier Inc.

Test Bank 4-2

A. misbranded

B. mislabeled

C. adulterated

D. off-label

E. teratogenic

ANS: C. adulterated

3. 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

ANS: D. abbreviated new drug application

Copyright © 2013, 2010, 2006, 2000 by Saunders, an imprint of Elsevier Inc.

Test Bank 4-3

4. 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

ANS: E. deposition of immune complexes in blood vessel walls

Copyright © 2013, 2010, 2006, 2000 by Saunders, an imprint of Elsevier Inc.