(Edited 07/01/2012 11:01 AM) | Report

How are new drugs developed and FDA approved

Developing a new drug steps

Preclinical research (1-3 years, average 18 months)
Drug discovery, Initial Synthesis & Purification, Animal testing. At the end of preclinical research, a pharmaceutical company will file an Investigational New Drug Application (IND) with the FDA (The Food and Drug Administration).

Clinical trials (2-10 years, average 5 years)
If the FDA approves IND, tests of new drug can be done in humans. Thre are three stages of testing:


Phase 1: primarily focused on pharmacokinetics) - studies the activity and monitor potential toxicity
Phase 2: focused on pharmacodynamics - determines the drugs effectiveness
Phase 3: impact of drug on clinical outcome - determines the effects of the drugs and determine if any side effects are involved


NDA (New Drug Application) Review (2 months - 7 years, average 2 years)
The effectiveness and safety of the drug are reviewed by FDA.

Post-Marketing Surveillance (also known as Phase 4)
Evaluates the impact of the drug both of the in trems of safety and effectiveness in broad population
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