Gaois

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5 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #676845

    IATE #930980
    críochphointe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    críochphointe cliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Endpunkt
    de
    Definition festgelegtes Ziel einer klinischen Studie, anhand dessen festgestellt wird, ob eine angewendete Maßnahme (i.d.R. eine medizinische Behandlung) erfolgreich war Reference "vgl. Wikipedia http://de.wikipedia.org/wiki/Prim%C3%A4rer_Endpunkt (13.10.2009)"
    Comment "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
    Definition 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 Reference "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)"
    Comment "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
    Definition paramètre par lequel on évalue, au cours d'un essai clinique, les effets d'une intervention thérapeutique chez des sujets Reference "Office québecois de la langue française > Grand dictionnaire terminologique > critère d'évaluation (21.9.2023)"
  3. SOCIAL QUESTIONS|health|medical science

    #643724

    IATE #3517053
    rinn-chríochphointe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    apikaler Endpunkt
    de
    Definition Auslösen einer Wirkung auf Populationsebene Reference "Verordnung (EU) Nr. 2017/735 der Kommission zur Änderung — zwecks Anpassung an den technischen Fortschritt — des Anhangs der Verordnung (EG) Nr. 440/2008 zur Festlegung von Prüfmethoden gemäß der Verordnung (EG) Nr. 1907/2006 des Europäischen Parlaments und des Rates zur Registrierung, Bewertung, Zulassung und Beschränkung chemischer Stoffe (REACH) CELEX:32017R0735/DE"
    apical endpoint | endpoints | apical effect
    en
    Definition in toxicology studies, empirically verifiable outcomes of exposure, such as developmental anomalies, breeding behaviors, impaired reproduction, physical changes and alterations in the size and histopathology of organs, and, of course, death Reference "Eddy Ball. Committee Proposes Paradigm Shift in Toxicity Testing. NIEHS. Environmental Factor. September 2007. http://www.niehs.nih.gov/news/newsletter/2007/september/toxicitytesting.cfm [25.2.2010]"
    critère d'évaluation apical | critères d'évaluation apicaux | critère apical d'évaluation | critères apicaux d'évaluation
    fr
    Comment "Le besoin de qualifier les critères d'évaluation en toxicologie par l'emploi de l'adjectif ""apical"" ne se fait sentir que lorsqu'on introduit l'idée d'autres critères que les modifications physiologiques observables et mesurables (critères traditionnels). Voir le contexte EN."
  5. SOCIAL QUESTIONS|health|pharmaceutical industry

    #676847

    IATE #931002
    críochphointe ionaid Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    surrogate endpoint
    en
    Definition "in clinical trials, measure of the effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship" Reference "COM-Terminology Coordination, based on: COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Strengthening of the EU Cooperation on Health Technology Assessment (HTA) Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU"
    Comment For example, the serum cholesterol concentration may be considered a surrogate endpoint when assessing pharmaceuticals aiming to prevent complications of cardiovascular disease. However, only about 10% of those with serum cholesterol concentration above the reference range are going to have a stroke or heart attack. Therefore more relevant clinical endpoints could be the number of nonfatal myocardial infarction or stroke cases.
    marqueur de substitution | critère de substitution | critère d'évaluation de substitution
    fr
    Definition marqueur aisément mesurable qui permet, en l’absence de données cliniques, d’évaluer l’effet d’un traitement Reference "Délégation générale à la langue française et aux langues de France (DGLFLF), FranceTerme, fiche ""marqueur de substitution"" (30.7.2020)"