NAPSRX CNPR Exam (Revised 18th
Edition)
what does a STAT order mean? - Answer-a drug needed immediately and given only once
what information does the overdosage section of the labeling provide? - Answer-signs, symptoms and
treatment of acute overdoses
types of drug-drug interactions: - Answer-duplication, opposition (antagonism) and alteration (p.51)
tolerance vs resistance - Answer-tolerance is the diminished response to a drug; resistance is the cells
ability to resist the effects of the drug on them.
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, no duplicate testing (p. 75)
the Hatch-Waxman Act of 1984 - Answer--A.K.A. Drug Price Competition and Patent Restoration Act
-made it easier to bring generic drugs to the market by requiring the FDA to only look at bioavailability
studies in order to approve an ANDA.
-gave protection to the research based manufacturers by providing a 30-month automatic cooling off
period once an ANDA is challenged for patent infringement (p. 75)
, four basic transport mechanisms - Answer-passive diffusion, facilitated diffusion, active transport, and
pinocytosis (p. 95)
potency vs efficacy - Answer-potency: amount of drug necessary to produce desired effect
efficacy: magnitude of maximal response that can be received from a drug
*efficacy is almost always more important that potency* (p. 106)
the four phases of clinical trials - Answer-phases I-IV (P. 124-126)
Key Parts Of A Clinical Paper (5) - Answer-Abstract, Introduction, methods, results,
discussion/conclusions (p. 128-129)
reliability vs validity - Answer-reliability = consistency and validity = accuracy
(p. 138; 143)
sampling error vs selection bias - Answer-sampling error is unbiased and is randomly chosen from the
population.
selection bias is when the sample was specifically chosen based on particular characteristics (p.142-143)
independent vs dependent variable - Answer-An independent variable is the one that influences the
variation. A dependent variable is the variable being tested and measured in a scientific experiment (the
result of applying the independent variable).
Drug Utilization Review (DUR) programs - Answer--involve retrospective monitoring of physicians'
prescribing patterns
-more than 90% of HMOs require DURs
-nowadays mostly monitors cost savings (p. 181)
Edition)
what does a STAT order mean? - Answer-a drug needed immediately and given only once
what information does the overdosage section of the labeling provide? - Answer-signs, symptoms and
treatment of acute overdoses
types of drug-drug interactions: - Answer-duplication, opposition (antagonism) and alteration (p.51)
tolerance vs resistance - Answer-tolerance is the diminished response to a drug; resistance is the cells
ability to resist the effects of the drug on them.
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, no duplicate testing (p. 75)
the Hatch-Waxman Act of 1984 - Answer--A.K.A. Drug Price Competition and Patent Restoration Act
-made it easier to bring generic drugs to the market by requiring the FDA to only look at bioavailability
studies in order to approve an ANDA.
-gave protection to the research based manufacturers by providing a 30-month automatic cooling off
period once an ANDA is challenged for patent infringement (p. 75)
, four basic transport mechanisms - Answer-passive diffusion, facilitated diffusion, active transport, and
pinocytosis (p. 95)
potency vs efficacy - Answer-potency: amount of drug necessary to produce desired effect
efficacy: magnitude of maximal response that can be received from a drug
*efficacy is almost always more important that potency* (p. 106)
the four phases of clinical trials - Answer-phases I-IV (P. 124-126)
Key Parts Of A Clinical Paper (5) - Answer-Abstract, Introduction, methods, results,
discussion/conclusions (p. 128-129)
reliability vs validity - Answer-reliability = consistency and validity = accuracy
(p. 138; 143)
sampling error vs selection bias - Answer-sampling error is unbiased and is randomly chosen from the
population.
selection bias is when the sample was specifically chosen based on particular characteristics (p.142-143)
independent vs dependent variable - Answer-An independent variable is the one that influences the
variation. A dependent variable is the variable being tested and measured in a scientific experiment (the
result of applying the independent variable).
Drug Utilization Review (DUR) programs - Answer--involve retrospective monitoring of physicians'
prescribing patterns
-more than 90% of HMOs require DURs
-nowadays mostly monitors cost savings (p. 181)
