Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648543

    IATE #3542054
    nochtadh carnach an duine is ábhar don tástáil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    kumulative Probandenexposition
    de
    cumulative subject exposure | cumulative summary tabulations
    en
    Definition "cumulative exposure [ IATE:3542055 ] of all subjects from ongoing and completed clinical trials exposed to the investigational medicinal product, placebo, and/or active comparator(s)" Reference "COM-EN, based on:European Medicines Agency. ICH guideline E2F Note for guidance on development safety update reports. Step 4 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/09/WC500097061.pdf [29.3.2012] & European Medicines Agency. Guideline on good pharmacovigilance practices (GVP)Module VII – Periodic safety update report http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129136.pdf [19.9.2012]"
    Comment "Not to be confused with cumulative patient exposure [ IATE:3542056 ]"
    exposition cumulée du sujet
    fr
    Definition "exposition cumulée [ IATE:3542055 ] d'un sujet à une substance au cours d'un essai clinique" Reference TERM-FR, d'après diverses sources.
    Comment "A ne pas confondre avec le terme exposition cumulée du patient [ IATE:3542056 ]"