Drug Development Flashcards

1
Q

3 Stages of Drug Development

A

Pre-clinical research
Clinical Trials
New Drug Application

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2
Q
A stage in drug development. 
Laboratory and Animal Testing
To assess safety and biological activity
5000 compounds evaluated
3.5 years
A

Pre clinical research

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3
Q

Phase 1, 2, 3 of Drug Development
1 Determine Safety and Dosage, 20-80 Volunteers
2 Evaluate Effectiveness, Side Effects, 100-300 Volunteers
3 Verify Effectiveness, monitor long term use reactions 1k-3k volunteers
5 enter trials
6 years

A

Clinical Trials

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4
Q

Drug Development Phase Where Post marketing testing required by FDA
Phase 4 clinical trials

A

New Drug Applications

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