NAPSRx CNPR exam (Revised 18th
Edition)
what does a STAT order mean? - correct answer-a drug needed immediately and given
only once
what information does the overdosage section of the labeling provide? - correct answer-
signs, symptoms and treatment of acute overdoses
types of drug-drug interactions: - correct answer-duplication, opposition (antagonism)
and alteration (p.51)
tolerance vs resistance - correct 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) - correct 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 - correct 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 - correct answer-passive diffusion, facilitated diffusion,
active transport, and pinocytosis (p. 95)
potency vs efficacy - correct 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 - correct answer-phases I-IV (P. 124-126)
Key Parts Of A Clinical Paper (5) - correct answer-Abstract, Introduction, methods,
results, discussion/conclusions (p. 128-129)
reliability vs validity - correct answer-reliability = consistency and validity = accuracy
Edition)
what does a STAT order mean? - correct answer-a drug needed immediately and given
only once
what information does the overdosage section of the labeling provide? - correct answer-
signs, symptoms and treatment of acute overdoses
types of drug-drug interactions: - correct answer-duplication, opposition (antagonism)
and alteration (p.51)
tolerance vs resistance - correct 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) - correct 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 - correct 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 - correct answer-passive diffusion, facilitated diffusion,
active transport, and pinocytosis (p. 95)
potency vs efficacy - correct 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 - correct answer-phases I-IV (P. 124-126)
Key Parts Of A Clinical Paper (5) - correct answer-Abstract, Introduction, methods,
results, discussion/conclusions (p. 128-129)
reliability vs validity - correct answer-reliability = consistency and validity = accuracy
