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1. what does a STAT order a drug needed immediately and given only once
mean?
2. what information does the signs, symptoms and treatment of acute overdoses
overdosage section of the
labeling provide?
3. types of drug-drug interac- duplication, opposition (antagonism) and alteration (p.51)
tions:
4. 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.
5. abbreviated new drug ap- the process by which applicants must scientifically demonstrate to
plication (ANDA) the FDA that their generic product is bioequivalent to or performs in
the same way as the innovator drug, no duplicate testing (p. 75)
6. the Hatch-Waxman Act of -A.K.A. Drug Price Competition and Patent Restoration Act
1984 -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)
7. four basic transport mech- passive diffusion, facilitated diffusion, active transport, and pinocy-
anisms tosis (p. 95)
8. 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)
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, NAPSRx CNPR exam (Revised 18th Edition)
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9. the four phases of clinical phases I-IV (P. 124-126)
trials
10. Key Parts Of A Clinical Pa- Abstract, Introduction, methods, results, discussion/conclusions (p.
per (5) 128-129)
11. reliability vs validity reliability = consistency and validity = accuracy
(p. 138; 143)
12. sampling error vs selection sampling error is unbiased and is randomly chosen from the pop-
bias ulation.
selection bias is when the sample was specifically chosen based on
particular characteristics (p.142-143)
13. independent vs dependent An independent variable is the one that influences the variation.
variable A dependent variable is the variable being tested and measured
in a scientific experiment (the result of applying the independent
variable).
14. Drug Utilization Review -involve retrospective monitoring of physicians' prescribing pat-
(DUR) programs terns
-more than 90% of HMOs require DURs
-nowadays mostly monitors cost savings (p. 181)
15. opportunity cost based on the premise that all resources are scarce, and therefore
every time we choose to use a resource it reduces the possibility of
it being used in another way.
16. what type of DTC advertis- Disease-state or unbranded ads (provides public information on a
ing is the only legal form in disease, not a drug)
Europe? (p. 223)
17.
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