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Descriptor English: Investigational New Drug Application
Descriptor Spanish: Aplicación de Nuevas Drogas en Investigación
Descriptor Portuguese: Aplicação de Novas Drogas em Teste
Descriptor French: Présentation de nouveau médicament de recherche
Entry term(s): Investigational New Drug Applications
Tree number(s): E05.290.250.400
E05.337.300.400
VS2.002.003.001.002
RDF Unique Identifier: https://id.nlm.nih.gov/mesh/D017387
Scope note: 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.)
Annotation: U.S. or foreign, but if U.S., new drug "must be submitted to the FDA" before study in humans
Allowable Qualifiers: EC economics
HI history
LJ legislation & jurisprudence
MT methods
OG organization & administration
SN statistics & numerical data
Previous Indexing: Drugs, Investigational (1990-1992)
Public MeSH Note: 93
History Note: 93
Entry Version: IND APPLICATION
DeCS ID: 30681
Unique ID: D017387
Documents indexed in the Virtual Health Library (VHL): Click here to access the VHL documents
Date Established: 1993/01/01
Date of Entry: 1992/05/20
Revision Date: 2018/06/29
Investigational New Drug Application - Preferred
Concept UI M0026403
Scope note 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.)
Preferred term Investigational New Drug Application
Entry term(s) Investigational New Drug Applications



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