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DeCS
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Descriptor English:
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Investigational New Drug Application
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Descriptor Spanish:
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Aplicación de Nuevas Drogas en Investigación
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Descriptor Portuguese:
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Aplicação de Novas Drogas em Teste
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Synonyms English:
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Investigational New Drug Applications
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Tree Number:
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E05.290.250.400
E05.337.300.400
VS2.002.003.001.002
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Definition English:
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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.) |
Indexing Annotation English:
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U.S. or foreign, but if U.S., new drug "must be submitted to the FDA" before study in humans; DF: IND APPLICATION
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History Note English:
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93
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Allowable Qualifiers English:
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Record Number:
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30681
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Unique Identifier:
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D017387
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Occurrence in VHL:
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Similar:
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DeCS
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