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Investigational new drug application

From Biology-Online Dictionary | Biology-Online Dictionary
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Investigational new drug application

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.