Gaois

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  1. SOCIAL QUESTIONS|health|medical science|toxicology

    #602204

    IATE #153630
    staidéar eachtarshuímh tocsaineolaíoch Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    staidéar eachtarshuímh Reference 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
    Definition 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 Reference "COM-EN, based on:European Medicines Agency. ICH Topic E 5 (R1); 'Ethnic Factors in the Acceptability of Foreign Clinical Data' (10.3.2023)"