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žiadosť o povolenie klinického skúšania nového lieku
Record number d017387 Date 06.06.2025 Type M - MESH Topical term žiadosť o povolenie klinického skúšania nového lieku Other term Slovak (Pseudonym) povoľovanie klinického skúšania nového lieku
See also (Later heading) lieky skúšané
UDC E05.290.250.400E05.337.300.400 Note 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.) subject heading
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