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NAPSRx® PHARMACEUT CNPR - Quiz Bank (Latest Quiz 1-Quiz 20) All Answers Correct.
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NAPSRx® PHARMACEUT CNPR - Quiz Bank (Latest Quiz 1-Quiz 20) All Answers Correct.
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the process by which applicants must scientifically demonstrate to the FDA that theirabbreviated new drug application (ANDA) generic product is bioequivalent to or performs in the same way as the innovator drug,
no duplicate testing (p. 75)
-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.
the Hatch-Waxman Act of 1984
-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 passive diffusion, facilitated diffusion, active transport, and pinocytosis (p. 95)
potency: amount of drug necessary to produce desired effect
potency vs efficacy 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 phases I-IV (P. 124-126)
Key Parts Of A Clinical Paper (5) Abstract, Introduction, methods, results, discussion/conclusions (p. 128-129)
reliability = consistency and validity = accuracy
reliability vs validity
(p. 138; 143)
sampling error is unbiased and is randomly chosen from the population.
sampling error vs selection bias selection bias is when the sample was specifically chosen based on particular
characteristics (p.142-143)
An independent variable is the one that influences the variation. A dependent variable
independent vs dependent variable is the variable being tested and measured in a scientific experiment (the result of
applying the independent variable).
-involve retrospective monitoring of physicians' prescribing patterns
Drug Utilization Review (DUR) programs -more than 90% of HMOs require DURs
-nowadays mostly monitors cost savings (p. 181)
based on the premise that all resources are scarce, and therefore every time we choose
opportunity cost
to use a resource it reduces the possibility of it being used in another way.
what type of DTC advertising is the only Disease-state or unbranded ads (provides public information on a disease, not a drug)
legal form in Europe? (p. 223)
company reps can only offer occasional meals as long as they are modest, and only
can pharm sales reps offer doctors meals?
offered in an office/hospital setting in conjunction with an educational presentation. (p.
(PhRMA code)
228)
FAQ about the PhRMA code p. 268-274
Urology and selling to Urologists p. 300-301
they serve as educators and field-based medical resources. they interface between
what is a Medical Science Liaison (MLS)?
their company and healthcare leaders.
- push-through refers to the company's overall efforts to demonstrate clinical efficiency
and efficacy and cost effectiveness of a product.
push through vs pull through sales strategies
- pull-through generates demand for the product, usually in ways consistent with the
health plans goals and guidelines. (p. 311)
https://www.fda.gov/about-fda/oncology-center-excellence/how-do-i-use-
drug labeling requirements FDA
prescription-drug-labeling#Section-10
What is predictive validity? the ability of an indicator to correctly predict an outcome.
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