NAPSRX FINAL EXAM PREP QUESTIONS
AND ANSWERS FULL SOLUTION GRADED
A+
⩥ 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)
AND ANSWERS FULL SOLUTION GRADED
A+
⩥ 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)
