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2 thoradh

  1. SOCIAL QUESTIONS|health|pharmaceutical industry
    críochphointe Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    críochphointe cliniciúil Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Endpunkt
    de
    Sainmhíniú festgelegtes Ziel einer klinischen Studie, anhand dessen festgestellt wird, ob eine angewendete Maßnahme (i.d.R. eine medizinische Behandlung) erfolgreich war Tagairt "vgl. Wikipedia http://de.wikipedia.org/wiki/Prim%C3%A4rer_Endpunkt (13.10.2009)"
    Nóta "Es wird unterschieden zwischen primären Endpunkten (Hauptziel einer Studie - z.B. Überlebensrate oder Rückfallrisiko, i.d.R. messbare Größen) und sekundären Endpunkten (zweitrangiges Ziel einer Studie, oftmals nicht messbare Größen wie Schmerzen, Lebensqualität). [ vgl. Wikipedia http://de.wikipedia.org/wiki/Sekund%C3%A4rer_Endpunkt , 13.10.2009]"
    clinical endpoint | clinical trial endpoint | endpoint | end point | end-point
    en
    Sainmhíniú clinically relevant outcome, accepted in medical practice (e.g. by regulatory guidance or professional society guidelines) and sufficiently sensitive and specific to detect the anticipated effect of the treatment Tagairt "COM-Terminology Coordination, based on:European Medicines Agency (EMA). 'ICH guideline E17 on general principles for planning and design of multi-regional clinical trials Step 5' (14.12.2023)"
    Nóta "A clinical trial might use a clinical endpoint or a surrogate endpoint. A clinical endpoint is an outcome that represents direct clinical benefit, such as survival, decreased pain, or the absence of disease."
    critère d'évaluation principal | critère d'efficacité | critère de jugement
    fr
    Sainmhíniú paramètre par lequel on évalue, au cours d'un essai clinique, les effets d'une intervention thérapeutique chez des sujets Tagairt "Office québecois de la langue française > Grand dictionnaire terminologique > critère d'évaluation (21.9.2023)"
  2. SOCIAL QUESTIONS|health|pharmaceutical industry
    príomh-chríochphointe Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comhthéacs 'Beidh an príomh-chríochphointe iomchuí don fheiste agus beidh sé ábhartha go cliniciúil.' Tagairt "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
    Sainmhíniú "outcome that establishes the efficacy, and/or safety features, of a medicinal product and for which a trial is powered" Tagairt "COM-Terminology Coordination, based on: - FDA. 'Multiple Endpoints in Clinical Trials Guidance for Industry' (2.6.2023)- Wikipedia > 'Clinical endpoint' (2.6.2023)"