PHARMACEUTICAL SALES CERTIFICATION REVIEW ||
VERIFIED QUESTIONS & ANSWERS || HIGH-YIELD STUDY
GUIDE || COMPLETE TEST BANK || GRADED A+
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
(p. 138; 143)
sampling error vs selection bias - CORRECT ANSWER -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)
independent vs dependent variable - CORRECT ANSWER -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 - CORRECT ANSWER --
involve retrospective monitoring of physicians' prescribing patterns
-more than 90% of HMOs require DURs
-nowadays mostly monitors cost savings (p. 181)