Gaois

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2 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #676201

    IATE #910208
    príomh-chríochphointe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Beidh an príomh-chríochphointe iomchuí don fheiste agus beidh sé ábhartha go cliniciúil.' Reference "Rialachán (AE) 2017/745 maidir le feistí leighis, lena leasaítear Treoir 2001/83/CE, Rialachán (CE) Uimh. 178/2002 agus Rialachán (CE) Uimh. 1223/2009 agus lena n-aisghairtear Treoir 90/385/CEE ón gComhairle agus Treoir 93/42/CEE ón gComhairle, CELEX:32017R0745/GA"
    primary endpoint | primary end point | primary end-point | primary clinical endpoint
    en
    Definition "outcome that establishes the efficacy, and/or safety features, of a medicinal product and for which a trial is powered" Reference "COM-Terminology Coordination, based on: - FDA. 'Multiple Endpoints in Clinical Trials Guidance for Industry' (2.6.2023)- Wikipedia > 'Clinical endpoint' (2.6.2023)"
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688175

    IATE #3639820
    críochphointe comhphríomhúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    co-primary endpoint
    en
    Definition "any of a set of outcomes that establishes the efficacy, and/or safety features, of a medicinal product in order to support regulatory action where there are two or more different features that are so critically important to the disease under study that a medicinal product will not be considered effective without demonstration of a treatment effect on all of these disease features" Reference "COM-Terminology Coordination, based on: FDA. 'Multiple Endpoints in Clinical Trials Guidance for Industry' (2.6.2023)"