Edition Questions and Correct Answers
Latest Updated GRADED A+
What does a STAT order mean? - CORRECT ANSWERS a drug needed
immediately and given only once
What information does the overdosage section of the labeling provide? -
CORRECT ANSWERS signs, symptoms and treatment of acute overdoses
types of drug-drug interactions: - CORRECT ANSWERS duplication,
opposition (antagonism) and alteration (p.51)
tolerance vs resistance - CORRECT ANSWERS 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 ANSWERS 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 ANSWERS -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 ANSWERS passive diffusion,
facilitated diffusion, active transport, and pinocytosis (p. 95)
potency vs efficacy - CORRECT ANSWERS 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 ANSWERS phases I-IV (P. 124-
126)
, Key Parts Of A Clinical Paper (5) - CORRECT ANSWERS Abstract,
Introduction, methods, results, discussion/conclusions (p. 128-129)
reliability vs validity - CORRECT ANSWERS reliability = consistency and
validity = accuracy
(p. 138; 143)
sampling error vs selection bias - CORRECT ANSWERS 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 ANSWERS 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 ANSWERS -involve
retrospective monitoring of physicians' prescribing patterns
-more than 90% of HMOs require DURs
-nowadays mostly monitors cost savings (p. 181)
opportunity cost - CORRECT ANSWERS 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? - CORRECT
ANSWERS 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) - CORRECT
ANSWERS company reps can only offer occasional meals as long as they are
modest, and only offered in an office/hospital setting in conjunction with an
educational presentation. (p. 228)
FAQ about the PhRMA code - CORRECT ANSWERS p. 268-274
Urology and selling to Urologists - CORRECT ANSWERS p. 300-301
what is a Medical Science Liaison (MLS)? - CORRECT ANSWERS they serve
as educators and field-based medical resources. they interface between their
company and healthcare leaders.