Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #619191

    IATE #1105999
    aonad dáileoige Reference "Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, CELEX:32014R0536/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Einnahmeeinheit | Gebrauchseinheit | Dosierungseinheit | Maßeinheit
    de
    Definition Darreichungsform eines Medikaments (Tablette, Ampulle usw.), die einer Dosis der Wirkstoffmenge entspricht Reference Council-DE
    dosage unit | dosage-unit | dose-unit | unit of dosage
    en
    Definition standardised pharmaceutical preparation of a drug corresponding to a single dose of the drug Reference "COM-EN, based on: - EMA. ICH Topic Q4B Annex 6 Uniformity of Dosage Units General Chapter - Step 3 - ANNEX 6 TO NOTE FOR EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON UNIFORMITY OF DOSAGE UNITS GENERAL CHAPTER (EMEA/CHMP/ICH/645408/2008) (21.2.2023)- British Pharmacopoeia - Volume IV Appendices - Appendix XII C. Consistency of Formulated Preparations (21.2.2023). "
    Comment i.e. one capsule, one tablet, the dose released by an inhaler at each puff, etc.