" /> investigational new drug application - CISMeF





Preferred Label : investigational new drug application;

MeSH 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.);

MeSH synonym : investigational new drug applications;

MeSH annotation : U.S. or foreign, but if U.S., new drug must be submitted to the FDA before study in humans; DF: IND APPLICATION; U.S. or foreign, but if U.S., new drug must be submitted to the FDA before study in humans;

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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.)

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26/04/2025


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