Product Knowledge Flashcards
7 cards from real CNPR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Product Knowledge flashcards as text
A 'contraindication' for a drug means:
Answer: A clinical situation in which the drug should NOT be used because the risks outweigh the benefits
A contraindication is a specific situation or condition in which a drug must not be used because the risk of harm clearly outweighs any potential benefit.
What does 'mechanism of action' (MOA) describe in pharmaceutical product knowledge?
Answer: How a drug produces its pharmacological effect at the molecular or cellular level
The mechanism of action explains how a drug interacts with its target (receptor, enzyme, ion channel, etc.) to produce its therapeutic effect.
Which route of drug administration typically provides the fastest onset of action?
Answer: Intravenous (IV)
Intravenous administration delivers the drug directly into the bloodstream, bypassing absorption and providing the fastest onset of action.
What is the role of the FDA's Adverse Event Reporting System (FAERS) in post-market drug surveillance?
Answer: It collects voluntary reports of adverse drug events to monitor drug safety after approval
FAERS is a database that supports the FDA's post-marketing safety surveillance by collecting and analyzing voluntary reports of adverse drug events and medication errors.
In clinical research, what distinguishes a 'double-blind' study design?
Answer: Neither the participants nor the investigators know who is receiving the treatment or placebo
In a double-blind study, neither the participants nor the researchers know who is in the treatment or control group, minimizing bias in reporting and assessment.
What is a 'generic equivalent' drug required to demonstrate to receive FDA approval?
Answer: Bioequivalence to the reference listed drug (RLD), meaning similar bioavailability
Generic drugs must demonstrate bioequivalence to the reference listed drug, meaning they deliver the same amount of active ingredient at the same rate to the site of action.
Which federal act requires pharmaceutical manufacturers to provide accurate and balanced information when promoting drugs to healthcare professionals?
Answer: The Federal Food, Drug, and Cosmetic Act (FD&C Act) and related FDA regulations
The FD&C Act and FDA regulations require that all drug promotion be truthful, non-misleading, and fairly balanced, presenting both benefits and risks.