|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.
||Laboratory and animal studies
||Assess safety and biological activity
||5,000 compounds evaluated|
|File IND at FDA|
||20 to 80 healthy volunteers
||Determine safety and dosage
||5 enter trials|
||100 to 300 patient volunteers
||Evaluate effectiveness, look for side effects|
||1000 to 3000 patient volunteers
||Verify effectiveness, monitor adverse reactions from long-term use|
|File NDA at FDA|
||Review process / Approval
||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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