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žiadosť o povolenie klinického skúšania nového lieku

  1. Subject h.žiadosť o povolenie klinického skúšania nového lieku
    Subject h.Investigational New Drug Application
    Entry termspovoľovanie klinického skúšania nového lieku
    Scope note in EnglishAn 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.)
    Links (41) - ARTICLES
    (1) - MeSH descriptor
    (3) - CiBaMed
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