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Cóip statach de shonraí a easpórtáiltear ó IATE ó am go chéile atá sa chnuasach seo. Níor cheart glacadh leis gurb ionann i gcónaí an t-eolas a thugtar faoi iontráil anseo agus a bhfuil sa leagan reatha den iontráil ar IATE. Is féidir an leagan reatha sin a cheadú ach cliceáil ar an nasc atá ar thaobh na láimhe deise ag barr gach iontrála. Breis eolais »

2 thoradh

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648543

    IATE #3542054
    nochtadh carnach an duine is ábhar don tástáil Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    kumulative Probandenexposition
    de
    cumulative subject exposure | cumulative summary tabulations
    en
    Sainmhíniú "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)" Tagairt "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]"
    Nóta "Not to be confused with cumulative patient exposure [ IATE:3542056 ]"
    exposition cumulée du sujet
    fr
    Sainmhíniú "exposition cumulée [ IATE:3542055 ] d'un sujet à une substance au cours d'un essai clinique" Tagairt TERM-FR, d'après diverses sources.
    Nóta "A ne pas confondre avec le terme exposition cumulée du patient [ IATE:3542056 ]"
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648545

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