COMPLETE QUESTIONS ACCURATE
ANSWERS
◉ Overdosage section of labeling. Answer: signs, symptoms and
treatment of acute overdoses
◉ Types of drug-drug interactions. Answer: duplication, opposition
(antagonism) and alteration
◉ 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
◉ 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.
,◉ Four basic transport mechanisms. Answer: passive diffusion,
facilitated diffusion, active transport, and pinocytosis
◉ 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
than potency.
◉ Four phases of clinical trials. Answer: phases I-IV
◉ Key Parts Of A Clinical Paper. Answer: Abstract, Introduction,
methods, results, discussion/conclusions
◉ Reliability vs Validity. Answer: reliability = consistency and validity
= accuracy
◉ 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.
◉ 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.
,◉ 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.
◉ 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.
◉ DTC advertising in Europe. Answer: Disease-state or unbranded ads
(provides public information on a disease, not a drug)
◉ PhRMA code on meals. Answer: 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.
◉ FAQ about the PhRMA code. Answer: p. 268-274
◉ Urology and selling to Urologists. Answer: p. 300-301
◉ Medical Science Liaison (MLS). Answer: they serve as educators and
field-based medical resources; they interface between their company and
healthcare leaders.
◉ Push through vs Pull through sales strategies. Answer: push-through
refers to the company's overall efforts to demonstrate clinical efficiency
and efficacy and cost effectiveness of a product.
, ◉ pull-through. Answer: generates demand for the product, usually in
ways consistent with the health plans goals and guidelines.
◉ predictive validity. Answer: the ability of an indicator to correctly
predict an outcome.
◉ criteria for mass advertising in pharmaceutical marketing. Answer:
*the size of the target patient population, the chronicity of the disease
state, the relevance of that disease state to its sufferers, the avg value of
a patient taking medication.
◉ AMA guidelines on subsidies. Answer: conference sponsors should
accept subsidies for continuing medical education conferences.
◉ decision maker in pharmaceutical sales. Answer: the physician.
◉ fast track drugs. Answer: drugs approved for serious or life-
threatening conditions.
◉ rebate. Answer: the amount that the manufacturer of a drug pays to an
insurer or health plan for each unit of drug dispensed.
◉ generic drug. Answer: a drug identical to a brand-name drug in
various aspects.