En ansökan som måste inlämnas till någon tillståndsmyndighet innan ett läkemedel kan få prövas på människor. Ansökan måste innehålla resultat av tidigare experiment; hur, var och av vem de nya prövningarna skall genomföras; föreningens kemiska struktur; vilken effekt man tänkt medlet skall ha i kroppen; eventuella toxiska effekter i djurexperiment samt hur medlet framställs.
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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Investigational New Drug Applications