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Investigative Techniques > Evaluation Studies as Topic > Drug Approval > Investigational New Drug Application
... > Health Care Quality, Access, and Evaluation > Quality of Health Care > Health Care Evaluation Mechanisms > Evaluation Studies as Topic > Drug Approval > Investigational New Drug Application
... > Health Occupations > Health Services Administration > Quality of Health Care > Health Care Evaluation Mechanisms > Evaluation Studies as Topic > Drug Approval > Investigational New Drug Application
Investigative Techniques > Drug Development > Drug Approval > Investigational New Drug Application
... > Health Care Economics and Organizations > Social Control, Formal > Legislation as Topic > Legislation, Drug > Drug and Narcotic Control > Drug Approval > Investigational New Drug Application
... > Behavioral Disciplines and Activities > Behavioral Sciences > Social Sciences > Sociology > Social Control, Formal > Legislation as Topic > Legislation, Drug > Drug and Narcotic Control > Drug Approval > Investigational New Drug Application
... > Health Occupations > Health Services Administration > Organization and Administration > Pharmacy Administration > Drug and Narcotic Control > Drug Approval > Investigational New Drug Application

Preferred term

Investigational New Drug Application  

Type

  • mesh:Descriptor

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.)

Broader concept

Related concepts

Entry terms

  • Investigational New Drug Applications

Allowable Qualifier(s)

In other languages

URI

http://data.loterre.fr/ark:/67375/JVR-WLJ4DG3S-4

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RDF/XML TURTLE JSON-LD Created 5/20/92, last modified 6/29/18