Drug R&D Process Overview (cont'd)
The Research & Development (or Drug) Pipeline
Figure 1: Drug Pipeline Chart
| Discovery | Synthesis, isolation, chemical and physical characterization |
| Biological Testing | Initial screening for potential activity, toxicity, and stability |
| Preclinical or Animal Testing | Extensive series of laboratory and animal studies to evaluate safety and biological activity against the targeted disease. |
| IND Filing | A document seeking approval from the FDA to begin clinical trials on human subjects |
| Clinical Trials | Phase I: Studies on 20-80
healthy volunteers to determine safe dosage ranges, absorption,
and metabolism. Phase II: Studies to evaluate efficacy and adverse effects in 100-300 volunteers with the targeted disease. Phase III: Studies to evaluate efficacy and long term adverse effects in 1,000-3,000 volunteers with the targeted disease. |
| Preregistration/ NDA Filing | A document seeking approval from the FDA to market the product. Often 100,000 pages or more consisting of research findings and other scientific information. |
| Registration/ Approval | The FDA approves a drug for marketing for interstate sales for specific dosage forms and indications. |
| Post-Marketing | Reports to the FDA of any adverse reactions or quality control issues. The FDA may also require Phase IV studies. Possible patent extensions, product recalls or withdrawal from market. |
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