Gaois

This is a static copy of data that is exported from IATE on an occasional basis. It should not be assumed that information provided about an entry here will always correspond to the current version of the entry in IATE. That current version can be checked by clicking on the link on the upper right hand side of each entry. More information »

1 result

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688349

    IATE #3640697
    staidéar cógaschinéitice fachtóra eistrigh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    extrinsic factor pharmaco-kinetics study | extrinsic factor PK study
    en
    Definition "human pharmacokinetic study that assesses differences in systemic exposure as a result of changes in pharmacokinetics due to extrinsic facrors" 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 Extrinsic ethnic factors are factors associated with the patient environment. Examples are the medical environment, use of other drugs (see 2.7.4.5.3, Drug Interactions), use of tobacco, use of alcohol, and food habits.