PRACTICE SOLUTIONS 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)
● 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.