With Practice Test Questions And Verified
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what does a STAT order mean? - ANS>> a drug needed immediately
and given only once
what information does the overdosage section of the labeling provide? -
ANS>> signs, symptoms and treatment of acute overdoses
types of drug-drug interactions: - ANS>> duplication, opposition
(antagonism) and alteration (p.51)
tolerance vs resistance - ANS>> 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) - ANS>> 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 - ANS>> -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)
, potency vs efficacy - ANS>> 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 - ANS>> phases I-IV (P. 124-126)
Key Parts Of A Clinical Paper (5) - ANS>> Abstract, Introduction,
methods, results, discussion/conclusions (p. 128-129)
reliability vs validity - ANS>> reliability = consistency and validity =
accuracy
(p. 138; 143)
sampling error vs selection bias - ANS>> 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)
four basic transport mechanisms - ANS>> passive diffusion, facilitated
diffusion, active transport, and pinocytosis (p. 95)
independent vs dependent variable - ANS>> 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 - ANS>> -involve
retrospective monitoring of physicians' prescribing patterns
-more than 90% of HMOs require DURs
-nowadays mostly monitors cost savings (p. 181)