Canadian Medical Guide > Analytical, Diagnostic and Therapeutic Techniques and Equipment > Investigative Techniques > Evaluation Studies > Drug Approval > Investigational New Drug Application Terms and Definitions

Investigational New Drug Application

Medical Definition:	An application that must be submitted to a regulatory agency (the FDA in the United States) before a drug can be studied in humans. This application includes results of previous experiments; how, where, and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in animal studies; and how the compound is manufactured. (From the "New Medicines in Development" Series produced by the Pharmaceutical Manufacturers Association and published irregularly.)
Guide Notes:	U.S. or foreign, but if U.S., new drug "must be submitted to the FDA" before study in humans; DF: IND APPLICATION
Previously Indexed:	Drugs, Investigational (1990-1992)

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