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  1. Premarketing studies in the drug approval process : Understanding their limitations regarding the assessment of drug safety.

    Article - En anglais

    This paper discusses the premarketing safety database that the US Food and Drug Administration receives from drug manufacturers.

    It reviews the kind of data we usually receive, what we do with the data, and how the data affect labeling.

    In addition, it discusses some of the limitations of that database in ensuring the safe use of medications.

    Mots-clés Pascal : Médicament, Industrie pharmaceutique, Recherche développement, Animal, Homme, Toxicité, Autorisation mise sur marché, Etats Unis, Amérique du Nord, Amérique

    Mots-clés Pascal anglais : Drug, Pharmaceutical industry, Research and development, Animal, Human, Toxicity, Marketing authorization, United States, North America, America

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 99-0125629

    Code Inist : 002B30A08. Création : 16/11/1999.