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Drug Development and Approval Process (USA)
Different stages of the drug development and approval process in the USA, lead from preclinical trials (testing in animals), first application in humans through limited and broad clinical tests, to postmarketing studies.

Years Test Population Purpose Success Rate
Preclinical Testing 3.5 Laboratory and animal studies Assess safety and biological activity 5,000 compounds evaluated
File IND at FDA
Phase I 1 20 to 80 healthy volunteers Determine safety and dosage 5 enter trials
Phase II 2 100 to 300 patient volunteers Evaluate effectiveness, look for side effects
Phase III 3 1000 to 3000 patient volunteers Verify effectiveness, monitor adverse reactions from long-term use
File NDA at FDA
FDA 2.5 Review process / Approval 1 approved
12 Total
Phase IV Additional Post marketing testing required by FDA

By Dale E. Wierenga, Ph.D. and C. Robert Eaton
Office of Research and Development
Pharmaceutical Manufacturers Association

'In reviewing this report, it is important to keep in mind the realities of the drug discovery and development process. The U.S. system of new drug approvals is perhaps the most rigorous in the world. On average, it costs a company $359 million to get one new medicine from the laboratory to the pharmacist's shelf, according to a February 1993 report by the Congressional Office of Technology Assessment.'
See also Phase 1 2 3 4 Drug Trials, Food and Drug Administration, and European Medicines Agency.
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Further Reading:
Guidelines for Developing Automated Quality Control Procedures for Brain Magnetic Resonance Images Acquired in Multi-Centre Clinical Trials
Tuesday, 26 April 2011   by    
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