|
1 / 1
|
DeCS
|
|
 |
|
Descriptor English:
|
|
Investigational New Drug Application
|
|
Descriptor Spanish:
|
|
Aplicación de Nuevas Drogas en Investigación
|
|
Descriptor Portuguese:
|
|
Aplicação de Novas Drogas em Teste
|
|
Synonyms English:
|
|
Investigational New Drug Applications
|
|
Tree Number:
|
|
E05.290.250.400
E05.337.300.400
VS2.002.003.001.002
|
|
Definition English:
|
|
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:
|
|
U.S. or foreign, but if U.S., new drug "must be submitted to the FDA" before study in humans; DF: IND APPLICATION
|
|
History Note English:
|
|
93
|
|
Allowable Qualifiers English:
|
|
|
|
Record Number:
|
|
30681
|
|
Unique Identifier:
|
|
D017387
|
Occurrence in VHL:
|
|
|
Similar:
|
|
DeCS
|