8 stages to the drug development process


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1. Discovery stage. Basic research synthesis of new checmicals and early studies of chemical properties. Identification of a specific new chemical entity worthy of further testing.
2. Preclinical animal testing. Short-term animal toxicity testing for evidence of safety in the short run in preparation for human testing.
3. IND filing. A request is made for authorization to begin human testing by filing a notice of claimed investigational exemption for new drug (IND). If there is no hold on the application, the firm begins climical testing 30 days after filing. (42.6 months for the first three stages)
4. Phase I of clinical testing. Dosage administered to a small number of healthy volunteers for information on toxicity and safe dose ranges in humans. Data are gathered on the drug’s absorption and distribution in the body, its metabolic effects, and the rate and manner in which the drug is eliminated from the body. (15.5 months)
5. Phase II of clinical testing. Drug is used on a larger number of people whom the drug is intended to benefit. Evidence of therapeutic effectiveness and additional safety data are obtained. (24.3 months)
6. Phase III of clinical testing. Large-scale tests on humans over a longer period to uncover unanticipated side effects and additional evidence of effectiveness. (36 months)
7. Long-term animal studies. The effects of prolonged exposures and the effects on subsequent generations are determined. Such studies are typically conducted concurrently with other studies. (33.6 months)
8. New drug approval. Application for commercial marketing of the new drug. Review of evidence by the FDA. Marketing for approved uses may begin upon notification by the FDA. (30.3 months)

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