?

Biochemistry

Free Version

Upgrade subject to access all content

Moderate

Understanding the Phases of a Clinical Trial

BIOCHM-13BEY7

Clinical trials contain five phases (0-4) in order to rigorously evaluate the efficacy and safety of a given drug or medical product.

Which of the following is the BEST description of phase 2?

A

Studies that occur after the drug has been approved for marketing by the FDA.

B

Studies that evaluate the efficacy and safety of the drug in various populations and at different dosages.

C

Exploratory or screening studies with limited drug exposure.

D

Studies that gather preliminary data on the efficacy of the drug as compared to a placebo or standard therapy in a specific, affected population.

E

Studies conducted with healthy volunteers to establish drug safety.