CNPR Product Knowledge 3

Question 1

Which phase of clinical trials specifically evaluates a new drug's safety and determines safe dosage ranges in a small group of healthy volunteers?

Accepted Answer

Phase I

Answer

Phase I trials are the first stage of human testing, focusing on safety, tolerability, pharmacokinetics, and dosage in a small group, usually 20–80 healthy volunteers.

Question 2

A pharmaceutical representative is asked by a physician about a use of the drug not covered in the approved labeling. The rep should:

Accepted Answer

Decline to discuss unapproved uses and offer to submit a medical information request

Answer

Reps must not promote off-label uses; the appropriate response is to acknowledge the question and direct the request to the medical affairs department for a proper medical information response.

Question 3

What is the difference between a drug's brand name and its generic name?

Accepted Answer

The brand name is the manufacturer's proprietary trade name; the generic name is the nonproprietary scientific name

Answer

The brand name is the proprietary name trademarked by the manufacturer, while the generic name is the official nonproprietary name established by the United States Adopted Names (USAN) Council.

Question 4

Which term describes the unintended effects of a drug that occur at therapeutic doses and are not related to the intended pharmacological action?

Accepted Answer

Side effects (adverse effects)

Answer

Side effects or adverse effects are undesired responses occurring at normal therapeutic doses that are separate from the drug's intended mechanism of action.

Question 5

In pharmacology, what does 'half-life' (t½) of a drug mean?

Accepted Answer

The time required for the plasma concentration of a drug to reduce by 50%

Answer

Half-life is the time required for the concentration of a drug in the bloodstream to decrease by half, which determines dosing intervals.

(CNPR) Certified National Pharmaceutical Representative Practice Test

(CNPR) Certified National Pharmaceutical Representative Practice Test

CNPR Product Knowledge 3