Pharmacotherapeutics Unit 2 Exam – Questions and Answers

Pharmacology Unit
2 exam

What is the primary purpose of Phase I clinical trials? - CORRECT ANSWER-Evaluate safety,
B B B B B B B B B B B BB B




dosage range, and side effects in a small group of healthy volunteers.
B B B B B B B B B B B B




What is the primary purpose of Phase II trials? - CORRECT ANSWER-Assess effectiveness and
B B B B B B B B B B BB B B




continue safety monitoring in patients with the disease.
B B B B B B B B




What is the primary purpose of Phase III trials? - CORRECT ANSWER-Confirm efficacy, monitor
B B B B B B B B B B BB B B




adverse reactions, compare to standard treatments.
B B B B B B




What is Phase IV? - CORRECT ANSWER-Post-marketing surveillance for rare or long-term adverse
B B B B B BB B B B B B B




effects.
B




What is Accelerated Approval? - CORRECT ANSWER-FDA approval based on surrogate endpoints
B B B B B BB B B B B B




for serious diseases with unmet needs.
B B B B B B




What is REMS? - CORRECT ANSWER-Risk Evaluation and Mitigation Strategy to ensure benefits
B B B B BB B B B B B B B




outweigh risks.
B B




For a generic drug to be bioequivalent, AUC and Cmax must fall within what range? - CORRECT
B B B B B B B B B B B B B B B B B




ANSWER-80%-125% of the brand-name drug.
B B B B B

, Which schedule has no accepted medical use? - CORRECT ANSWER-Schedule I.
B B B B B B B B BB B




Which schedule has the highest abuse potential with accepted medical use? - CORRECT
B B B B B B B B B B B B B




ANSWER-Schedule II.
B B




What does PDMP stand for? - CORRECT ANSWER-Prescription Drug Monitoring Program.
B B B B B B BB B B B




Pharmacokinetics means? - CORRECT ANSWER-What the body does to the drug.
B B B BB B B B B B B




Pharmacodynamics means? - CORRECT ANSWER-What the drug does to the body.
B B B BB B B B B B B




What is first-pass metabolism? - CORRECT ANSWER-Drug metabolism by the liver before
B B B B B BB B B B B B




reaching systemic circulation.
B B B




Which drugs cross the placenta most easily? - CORRECT ANSWER-Lipid-soluble, low molecular
B B B B B B B B BB B B




weight drugs.
B B




Which drugs cross the blood-brain barrier most easily? - CORRECT ANSWER-Lipid-soluble, non-
B B B B B B B B B BB B




ionized drugs.
B




What happens when a CYP450 inhibitor is added? - CORRECT ANSWER-Drug levels increase,
B B B B B B B B B BB B B




toxicity risk increases.
B B B




What happens when a CYP450 inducer is added? - CORRECT ANSWER-Drug levels decrease,
B B B B B B B B B BB B B




effectiveness decreases.
B B




What is First-order kinetics? - CORRECT ANSWER-Constant percentage eliminated per unit time.
B B B B B BB B B B B B