18TH EDITION) |VERIFIED | UPDATED
1. whatdoes a STATorder mean?
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..ANSWER>>a drug needed immediately and given only once c c c c c c c
2. what information does the overdosage
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section of the labeling provide?
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..ANSWER>>signs, symptoms and treatment of acute overdoses c c c c c c
3. types of drug-drug interac- duplication, opposition (antagonism) and alteration (p.51)
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tions:
4. tolerance vs resistance c c ..ANSWER>>tolerance is the diminished response to a drug; resistance is the cells c c c c c c c c c c c
ability to resist the ettects of the drug on them.
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5. abbreviated new drug ap- plication c c c c
..ANSWER>>the process by which applicants must scientifically demonstrate to the c c c c c c c c c
c (ANDA) c FDA that their generic product is bioequivalent to or performs in the same way as the
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c innovator drug, no duplicate testing (p. 75)
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6. theHatch-Waxman Act of 1984
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..ANSWER>>-A.K.A. Drug Price Competition and Patent Restoration Act c c c c c c c
-made it easier to bring generic drugs to the market by requiring the FDA to only look at
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c bioavailability studies in order to approve an ANDA.
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-gave protection to the research based manufacturers by providing a 30-month automatic cooling
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c ott period once an ANDA is challenged for patent infringement (p. 75)
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7. fourbasic transport mech- anisms
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..ANSWER>>passive dittusion, facilitated dittusion, active transport, and pinocy- tosis c c c c c c c c
c (p. 95)
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, 8. potency vs efficacy
c c ..ANSWER>>potency: amount of drug necessary to produce desired ettect
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eflcacy: magnitude of maximal response that can be received from a drug
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*eflcacy is almost always more important that potency* (p. 106)
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