Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #683668

    IATE #3557606
    staidéar bith-infhaighteachta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Soláthrófar tuarascálacha maidir le staidéar bith‑infhaighteachta, tuarascálacha maidir le staidéar comparáideach bith‑infhaighteachta agus bithchoibhéise, tuarascálacha maidir le staidéar comhghaoil in vitro agus in vivo, agus modhanna bith‑anailíse agus anailíse.' Reference "Togra le haghaidh Treoir maidir le Cód an Aontais a bhaineann le táirgí íocshláinte lena n‑úsáid ag an duine, agus lena n‑aisghairtear Treoir 2001/83/CE agus Treoir 2009/35/CE, CELEX:52023PC0192/GA"
    absolute bioavailability study | bio-availability study | bioavailability study
    en
    Definition "study to compare the bioavailability of a given dosage form in systemic circulation following non-intravenous administration with the bioavailability of the same medicine following intravenous administration" Reference "COM-Terminology Coordination, based on: EMA. 'NOTE FOR GUIDANCE ON THE INVESTIGATION OF BIOAVAILABILITY AND BIOEQUIVALENCE' (13.6.2023). COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP). London, 14 December 2000 CPMP/EWP/QWP/1401/98"
    Comment "Bioavailability of a drug administered intravenously is by definition 100%. Bioavailability is less or equal to 100% for any other route of administration.See also comparative bioavailability study"