Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research

    #683115

    IATE #3543765
    críochphointe éifeachtúlachta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'I gcás trialacha cliniciúla a chuirfear i gcrích i ngalar ardghalrachta nó ardmhortlaíochta, áfach, más rud é go bhféadfadh sé gur FDTNA-anna iad críochphointí éifeachtúlachta nó inar mortlaíocht nó toradh “tromchúiseach” eile (a fhéadfar a thuairisciú go hionchasach mar FDTNA) an críochphointe éifeachtúlachta i dtriail chliniciúil, féadfar sláine na trialach cliniciúla a chur i mbaol má bhristear an dalladh go córasach.' Reference "Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, CELEX:32014R0536/GA"
    Wirksamkeits-Endpunkt
    de
    efficacy endpoint | efficacy end-point
    en
    Definition "endpoint intended to reflect the effects of a medicinal product" Reference "COM-Terminology Coordination, based on: FDA. 'Multiple Endpoints in Clinical Trials Guidance for Industry' (2.6.2023)"
    Comment "There a can be primary or secondary efficacy endpoints, as secondary endpoints also may provide evidence that a particular mechanism underlies a demonstrated clinical effect (e.g., a drug for osteoporosis with fractures as the primary endpoint, and improved bone density as a secondary endpoint)."