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  2. New Drug Application - Wikipedia

    en.wikipedia.org/wiki/New_Drug_Application

    To legally test the drug on human subjects in the United States, the maker must first obtain an Investigational New Drug (IND) designation from FDA. [5] This application is based on nonclinical data, typically from a combination of in vivo and in vitro laboratory safety studies, that shows the drug is safe enough to test in humans. [5]

  3. Enzyme multiplied immunoassay technique - Wikipedia

    en.wikipedia.org/wiki/Enzyme_multiplied...

    Enzyme multiplied immunoassay technique (EMIT) is a common method for qualitative and quantitative determination of therapeutic and recreational drugs and certain proteins in serum and urine. [1] It is an immunoassay in which a drug or metabolite in the sample competes with a drug/metabolite labelled with an enzyme, to bind to an antibody. The ...

  4. Drug test - Wikipedia

    en.wikipedia.org/wiki/Drug_test

    A drug test (also often toxicology screen or tox screen) is a technical analysis of a biological specimen, for example urine, hair, blood, breath, sweat, or oral fluid/saliva—to determine the presence or absence of specified parent drugs or their metabolites.

  5. Drug development - Wikipedia

    en.wikipedia.org/wiki/Drug_development

    Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may ...

  6. Investigational New Drug - Wikipedia

    en.wikipedia.org/wiki/Investigational_new_drug

    The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.

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