Gaois

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  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688348

    IATE #3640696
    staidéar cógaschinéitice fachtóirí intreacha Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    intrinsic factor pharmaco-kinetics study | intrinsic factor PK study
    en
    Definition "human pharmacokinetic study that assesses differences in systemic exposure as a result of changes in pharmacokinetics due to intrinsic factors" Reference "COM-Terminology Coordination, based on: EMA. 'ICH Topic M 4 E Common Technical Document for the Registration of Pharmaceuticals for Human Use – Efficacy Step 5 COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE CLINICAL OVERVIEW AND CLINICAL SUMMARY OF MODULE 2 MODULE 5: STUDY REPORTS (CPMP/ICH/2887/99 - Efficacy)' (25.7.2023). July 2003 CPMP/ICH/2887/99 - Efficacy"
    Comment "Demographic and other factors defined as ""intrinsic ethnic factors"" in ICH E5. These factors include age, sex, height, weight, lean body mass, genetic polymorphism, body composition, other illness and organ dysfunction."