Qs (Revised 18th Edition) Actual
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what does a STAT order mean? - 🧠 ANSWER ✔✔a drug needed
immediately and given only once
,what information does the overdosage section of the labeling provide? - 🧠
ANSWER ✔✔signs, symptoms and treatment of acute overdoses
types of drug-drug interactions: - 🧠 ANSWER ✔✔duplication, opposition
(antagonism) and alteration (p.51)
tolerance vs resistance - 🧠 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) - 🧠 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 - 🧠 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 - 🧠 ANSWER ✔✔passive diffusion,
facilitated diffusion, active transport, and pinocytosis (p. 95)
potency vs efficacy - 🧠 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 - 🧠 ANSWER ✔✔phases I-IV (P. 124-126)
Key Parts Of A Clinical Paper (5) - 🧠 ANSWER ✔✔Abstract, Introduction,
methods, results, discussion/conclusions (p. 128-129)
reliability vs validity - 🧠 ANSWER ✔✔reliability = consistency and validity =
accuracy
(p. 138; 143)
sampling error vs selection bias - 🧠 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)
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, independent vs dependent variable - 🧠 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 - 🧠 ANSWER ✔✔-involve
retrospective monitoring of physicians' prescribing patterns
-more than 90% of HMOs require DURs
-nowadays mostly monitors cost savings (p. 181)
opportunity cost - 🧠 ANSWER ✔✔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.
what type of DTC advertising is the only legal form in Europe? - 🧠
ANSWER ✔✔Disease-state or unbranded ads (provides public information
on a disease, not a drug)
(p. 223)
can pharm sales reps offer doctors meals? (PhRMA code) - 🧠 ANSWER
✔✔company reps can only offer occasional meals as long as they are