IND

Investigational New Drug Application, an application to carry out human testing of a potential new drug, known as an NCE or New Chemical Entity. The IND process has three stages: Phase I, safety testing on a limited number of volunteers, say, 20-80; Phase II, testing for efficacy and side effects on a larger group of volunteers, 100-300; Phase III, testing on 1,000-3,000 or more patients to determine whether the drug meets risk/benefit criteria, i.e., do benefits outweigh potential side effects. Typically less than 27 percent of drugs that enter stage I complete stage III, and not all such drugs are then marketed commercially. See ANDA, Quasi-Intellectual Property.

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