Investigational New Drug Application
"Investigational New Drug Application" is a descriptor in the National Library of Medicine's controlled vocabulary thesaurus,
MeSH (Medical Subject Headings). Descriptors are arranged in a hierarchical structure,
which enables searching at various levels of specificity.
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.)
| Descriptor ID |
D017387
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| MeSH Number(s) |
E05.337.300.400
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| Concept/Terms |
|
Below are MeSH descriptors whose meaning is more general than "Investigational New Drug Application".
Below are MeSH descriptors whose meaning is more specific than "Investigational New Drug Application".
This graph shows the total number of publications written about "Investigational New Drug Application" by people in this website by year, and whether "Investigational New Drug Application" was a major or minor topic of these publications.
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click here.
| Year | Major Topic | Minor Topic | Total |
|---|
| 2008 | 1 | 0 | 1 |
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Below are the most recent publications written about "Investigational New Drug Application" by people in Profiles.
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Zhang Y, Zhang L, Abraham S, Apparaju S, Wu TC, Strong JM, Xiao S, Atkinson AJ, Thummel KE, Leeder JS, Lee C, Burckart GJ, Lesko LJ, Huang SM. Assessment of the impact of renal impairment on systemic exposure of new molecular entities: evaluation of recent new drug applications. Clin Pharmacol Ther. 2009 Mar; 85(3):305-11.