.fast track drugs refer to - ANSWER-drugs approved for serious or life-
threatening conditions
.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)
.according to the AMA guidelines, who should accept subsidies for continuing
medical education conferences? - ANSWER-conference sponsors
.can pharm sales reps offer doctors meals? (PhRMA code) - 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. (p. 228)
.drug labeling requirements FDA - ANSWER-https://www.fda.gov/about-
fda/oncology-center-excellence/how-do-i-use-prescription-drug-
labeling#Section-10
.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)
, .FAQ about the PhRMA code - ANSWER-p. 268-274
.four basic transport mechanisms - ANSWER-passive diffusion, facilitated
diffusion, active transport, and pinocytosis (p. 95)
.generic drug definition - ANSWER-a drug identical to a brand-name drug in
various aspects
.how can e-prescribing prevent abuse of controlled substances? - ANSWER-by
cross-checking regional e-prescriptions
.how can pharmaceutical sales representatives leverage clinical evidence to
address rumors? - ANSWER-present current clinical studies that address
concerns
.how can you set the mood for a successful speaker program during the event? -
ANSWER-Introduce the speaker and allow for a question-and-answer format
.in the methods section of a clinical paper, what info is provided? - ANSWER-
patient characteristics and demographics
.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).
.Key Parts Of A Clinical Paper (5) - ANSWER-Abstract, Introduction, methods,
results, discussion/conclusions (p. 128-129)