BCMAS exam - case study questions Answered Correctly
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Course
BCMAS
Institution
BCMAS
What type of application is required to start studying an investigation drug in humans - Correct Answer IND
What is the difference between a commercial IND and non-commercial IND applications - Correct Answer commercial INDs are sibmmited by corporate netities or orgnaizations for commercial...
BCMAS exam - case study questions
Answered Correctly
What type of application is required to start studying an investigation drug in humans - Correct Answer
IND
What is the difference between a commercial IND and non-commercial IND applications - Correct
Answer commercial INDs are sibmmited by corporate netities or orgnaizations for commercialization
non-commercial INDs are submitted by individual investigators for research or emergency purposes (i.e.
to treat serious, lifethreatening diseases). three types of non commercial INDs: investigator, emergency
use, and treatment
Which division would the IND applications be submitted to (for drug molecules) - Correct Answer CDER,
with the specific division based on disease area; CBER for cell and gene therapies, but most biologic
products (proetins, antibodies) are now submitted to CDER
How long do companies wait for a response after submitting an IND - Correct Answer 30 days
What are the steps for a company to take after receving an approved IND submission response? - Correct
Answer Complete the phase 3 trials; submit an NDA or BLA (depending on the molecule being studied)
to CDER for market approval
For breakthrough, first to market mAB products for a rare disease, what market protection are these
product eligible for - Correct Answer 7 year patent exclusitivity for orphan drug; biologic products are
already allowed 12 years exclusivity (filed under 351k application); these time frames may overlap and
not total 19 years
what does CDER review - Correct Answer mABs, cytokines, growth factors, enzymes,
immunomodulators, thrombolytics, preotins for therapietic use, non vaccine therapeutic
immunotherapies
what types of study do pharma companies conduct to assess safety after approval? are there FDA
manadated study designs? - Correct Answer post-marketing requirements from FDA mandate phase IV
, studies be conducted to evaluate safety in larger populations. RCT is gold standard but not required,
unless requested by FDA
what are survelliance studies - Correct Answer other post marketing studies requested by FDA to
understand drug interactions with other medications, use in special populations, for other formulations
advacements for use
what are benefits of post marketing studies to pharma companies - Correct Answer additional data to
expand indications, can conduct HEOR studies/Cost-benefit analyses, study combination products that
were not originally studied
how are AEs reported to the FDA in the real world? - Correct Answer MedWatch
what is the role of MA when FDA requires a label update to include a BBW? - Correct Answer
interactions with KOLs, education, prodcuing new medical materials, production of new package insert
what are sources for MI to use to respond to inquiries - Correct Answer lit search, SRs, package inserts,
etc
what are some lit search resources - Correct Answer embase, pubmed, OVID/medline, ACP journal,
dynamed, TRIP data base
what is level of evidence hierarchy per ACMA? - Correct Answer o Evidence from published clinical
practice guidelines
o Evidence obtained by meta-analysis and systematic reviews of several randomized controlled trials
(RCT)
o Evidence from only one RCT (experimental design)
o Evidence from controlled trials without randomization (these are known as quasi-experimental
designs)
o Evidence from observational-analytic studies, including prospective and retrospective cohort and case-
control studies
o Evidence from observational-descriptive studies, including cross-sectional studies, case series, and case
reports
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