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2024 MEDICAL PHARMACOLOGY EXAM WITH CORRECT ANSWERS
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2024 MEDICAL PHARMACOLOGY EXAM WITH CORRECT ANSWERS
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2024 MEDICAL PHARMACOLOGYEXAM WITH CORRECT ANSWERS
How long does it take to get a new drug to market? - CORRECT-ANSWERS12-
14 years
What is the average cost to make a new drug? - CORRECT-ANSWERS$500
million to $1 billion
Name 6 steps of Pharmaceutical R&D Pipeline - CORRECT-ANSWERS1.
Discovery: High throughput screening
2. Pre-clinical: lab/animal testing
3. Phase I: 2--100 volunteers for safety and dosage
4. Phase II: 100-500 volunteers for efficacy and side-effects
5. Phase III: 1,000- 1,500 volunteers for long-term use study
6. FDA review
What three areas do the R&D dollars go? - CORRECT-ANSWERSDiscovery:
23%
Preclinical Development: 12%
Clinical Research: 65%
How to determine which drug to develop (3 parts)? - CORRECT-ANSWERS1.
Lead ID: compounds believed to have potential as a disease treatment that
is potentially better than known substances.
2. Lead Optimization
3. Result
Briefly, what preclinical steps are needed to bring a drug to market? -
CORRECT-ANSWERSFirstly--lab bench work, therepeautic/marketing analysis,
finding a lead.
Secondly--pharmacologically evaluating candidates with in vitro, cell-based,
and animal disease models and narrowing them down.
Thirdly--assessing development challenges (toxicology/pharmacokinetics,
dose range studies).
Finally--Then apply to FDA.
What application must the drug sponsor submit in order to get permission
from the FDA to do clinical trials? - CORRECT-ANSWERSThe Investigational
New Drug App, which details the how, when, what, and who.
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