EDITION) QUESTIONS AND
ANSWERS RATED 100% CORRECT.
1. What does a STAT order mean?
Answer: A drug needed immediately and given only once.
2. What information does the overdosage section of the labeling provide?
Answer: Signs, symptoms, and treatment of acute overdoses.
3. What are the types of drug-drug interactions?
Answer: Duplication, opposition (antagonism), and alteration.
4. What is the difference between tolerance and resistance?
Answer: Tolerance is the diminished response to a drug; resistance is the cell's ability to resist
the effects of the drug on them.
5. What is an abbreviated new drug application (ANDA)?
Answer: The process by which applicants must scientifically demonstrate to the FDA that their
generic product is bioequivalent to or performs in the same way as the innovator drug, with no
duplicate testing.
6. What is the Hatch-Waxman Act of 1984?
Answer: Also known as the Drug Price Competition and Patent Restoration Act, it made it
easier to bring generic drugs to market by requiring the FDA to only review bioavailability
studies for ANDA approval and provided a 30-month automatic cooling-off period once an
ANDA is challenged for patent infringement.
, 7. What are the four basic transport mechanisms?
Answer: Passive diffusion, facilitated diffusion, active transport, and pinocytosis.
8. What is the difference between potency and efficacy?
Answer: Potency is the amount of drug necessary to produce the desired effect, while efficacy is
the magnitude of the maximal response that can be received from a drug. Efficacy is almost
always more important than potency.
9. What are the four phases of clinical trials?
Answer: Phases I-IV.
10. What are the key parts of a clinical paper?
Answer: Abstract, Introduction, Methods, Results, Discussion/Conclusions.
11. What is the difference between reliability and validity?
Answer: Reliability refers to consistency, and validity refers to accuracy.
12. What is the difference between sampling error and selection bias?
Answer: Sampling error is unbiased and randomly chosen from the population, while selection
bias occurs when the sample is specifically chosen based on particular characteristics.
13. What is the difference between an independent and dependent variable?
Answer: An independent variable influences the variation, while a dependent variable is the
variable being tested and measured in an experiment (the result of applying the independent
variable).
14. What are Drug Utilization Review (DUR) programs?
Answer: They involve retrospective monitoring of physicians' prescribing patterns. More than
90% of HMOs require DURs, which nowadays mostly monitor cost savings.