Gaois

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2 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #644054

    IATE #3518728
    foirmliú béil tobscaoilte Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    orale Darreichungsform mit sofortiger Wirkstofffreigabe
    de
    immediate-release oral pharmaceutical form | immediate-release oral dosage form | immediate release solid oral dosage form | immediate-release oral formulation
    en
    Definition "medicinal product1 formulated to allow the drug to dissolve in the gastrointestinal contents, with no intention of delaying or prolonging the dissolution or absorption of the drug1 medicinal product [ IATE:1443220 ]" Reference "COM-Terminology Coordination, based on:FDA. Guidance for Industry SUPAC-MR: Modified Release Solid Oral Dosage Forms. Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation, http://www.fda.gov/downloads/Drugs/Guidances/UCM070640.pdf [30.6.2014]"
    forme orale à libération immédiate | forme solide pour voie orale à libération immédiate
    fr
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #619279

    IATE #1106950
    foirm chógaisíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    pharmazeutische Form | Darreichungsform | Arzneimittelform
    de
    Definition Form, in der Arzneimittel verabreicht werden Reference Römpp Chemie-Lexikon, 8. Aufl., Stuttgart 1979
    pharmaceutical dose form | pharmaceutical form | pharmaceutical dosage form | dosage form
    en
    Definition combination of the form in which a pharmaceutical product is presented by the manufacturer (form of presentation) and the form in which it is administered, including the physical form (form of administration) Reference "'dosage form' (14.2.2024), Glossary of Fields in the Canada Vigilance Adverse Reaction Online Database, Government of Canada."
    Comment "A list of the different pharmaceutical dose forms can be found at: European Medicines Agency.Extended EudraVigilance product report message (XEVMPD) pharmaceutical dose forms, version 2.0 (8.2.2024) In the assessment of marketing authorisations applications in Europe, pharmaceutical forms that only differ with respect to the container/administration device may not always be considered as different pharmaceutical forms. European Commission. 'VOLUME 2C Regulatory Guidelines GUIDELINE ON THE CATEGORISATION OF EXTENSION APPLICATIONS (EA) versus VARIATIONS APPLICATIONS (V)' (26.6.2020) July 2019"
    forme galénique | forme pharmaceutique | forme médicamenteuse
    fr
    Definition aspect sous lequel un produit pharmaceutique est présenté par le fabricant (comprimé, gélule, suppositoire, ...) mais également forme d'administration de ce produit pharmaceutique Reference "COM-FR, d'après: Doctissimo, Dictionnaire médical, Galénique, http://dictionnaire.doctissimo.fr/definition-galenique.htm [1.7.2014]"