Gaois

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 »

1 toradh

  1. SOCIAL QUESTIONS|health|medical science|toxicology
    staidéar eachtarshuímh tocsaineolaíoch Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    staidéar eachtarshuímh Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    toxikologische Brückenstudie
    de
    bridging study | bridging studies | toxicological bridging study | toxicological bridging studies | bridging analysis | bridging analyses
    en
    Sainmhíniú supplemental study performed in a new region (region where product registration is sought) to provide pharmacodynamic or clinical data on efficacy, safety, dosage and dose regimen in the new region that will allow extrapolation of the foreign clinical data to the population in the new region Tagairt "COM-EN, based on:European Medicines Agency. ICH Topic E 5 (R1); 'Ethnic Factors in the Acceptability of Foreign Clinical Data' (10.3.2023)"