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  1. Post-approval drug research : Objectives and methods.

    Article - En anglais

    The limitations of pre-marketing clinical trials are analyzed and the need for ongoing drug research after approval is emphasized.

    Rare adverse drug reactions constitute the most important but not the only question.

    In addition to so-called post-marketing Drug Utilization Oberservation studies and spontaneous event reporting systems, other pharmacoepidemiologic study approaches like comparative cohort studies and case control studies, and also randomized clinical trials, are necessary to meet the multitude of scientific objectives of post-approval drug research.

    Mots-clés Pascal : Autorisation mise sur marché, Essai clinique, Recherche scientifique, Facteur risque, Toxicité, Homme, Allemagne, Europe

    Mots-clés Pascal anglais : Marketing authorization, Clinical trial, Scientific research, Risk factor, Toxicity, Human, Germany, Europe

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

    Cote : 97-0120379

    Code Inist : 002B02A07. Création : 21/05/1997.