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Terms in this set (649)
what does a STAT order mean? a drug needed immediately and given only once
what information does the signs, symptoms and treatment of acute
overdosage section of the labeling overdoses
provide?
types of drug-drug interactions: duplication, opposition (antagonism) and
alteration (p.51)
tolerance vs resistance 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 the process by which applicants must
(ANDA) 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 -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 passive diffusion, facilitated diffusion, active
transport, and pinocytosis (p. 95)
potency vs efficacy 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 phases I-IV (P. 124-126)
Key Parts Of A Clinical Paper (5) Abstract, Introduction, methods, results,
discussion/conclusions (p. 128-129)
reliability vs validity reliability = consistency and validity = accuracy
(p. 138; 143)
sampling error vs selection bias 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)