Gaois

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1 toradh

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688347

    IATE #3640695
    staidéar cógaschinéitice ar othair Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    patient pharmaco-kinetics study | patient PK study
    en
    Sainmhíniú "human pharmacokinetic study where the study population is selected within the intended patient population" Tagairt "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"