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 |
|---|
| 2017 | 1 | 2 | 3 |
| 2018 | 0 | 1 | 1 |
| 2020 | 0 | 2 | 2 |
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Below are the most recent publications written about "Investigational New Drug Application" by people in Profiles.
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Evaluating SARS-CoV-2 Vaccines After Emergency Use Authorization or Licensing of Initial Candidate Vaccines. JAMA. 2021 01 19; 325(3):221-222.
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Outpatient Inhaled Nitric Oxide in a Patient with Vasoreactive Idiopathic Pulmonary Arterial Hypertension and COVID-19 Infection. Am J Respir Crit Care Med. 2020 07 01; 202(1):130-132.
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Deployment of convalescent plasma for the prevention and treatment of COVID-19. J Clin Invest. 2020 06 01; 130(6):2757-2765.
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Treatment of Coronavirus Disease 2019 (COVID-19) Patients with Convalescent Plasma. Am J Pathol. 2020 08; 190(8):1680-1690.
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The FDA Breakthrough-Drug Designation - Four Years of Experience. N Engl J Med. 2018 04 12; 378(15):1444-1453.
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Experience of an academic institute in importing a novel preclinical drug into India. Indian J Pharmacol. 2017 Jul-Aug; 49(4):322-324.
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Amid FDA Approval Filings, Another CAR-T Therapy Patient Death. JAMA. 2017 Jun 13; 317(22):2271.
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Most of the Intended Management Changes After 68Ga-DOTATATE PET/CT Are Implemented. J Nucl Med. 2017 11; 58(11):1793-1796.