Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648545

    IATE #3542056
    nochtadh carnach othair Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    kumulative Patientenexposition
    de
    cumulative patient exposure | cumulative summary tabulations
    en
    Definition "cumulative exposure [ IATE:3542055 ] of all persons to a marketed drug since the international birth date [ IATE:3542058 ] of the medicinal product" Reference "COM-EN, based on:European Medicines Agency. ICH guideline E2FNote 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]"
    Comment "Not to be confused with cumulative subject exposure [ IATE:3542054 ]"
    exposée cumulée du patient
    fr
    Definition "exposition cumulée [ IATE:3542055 ] d'un patient à un médicament depuis sa date de naissance internationale [ IATE:3542058]" Reference TERM-FR, d'après diverses sources.
    Comment "A ne pas confondre avec le terme exposition cumulée du sujet [ IATE:3542054 ]"