Gaois

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  1. SCIENCE|natural and applied sciences|life sciences|pharmacology

    #687711

    IATE #3637135
    staidéar ar chógaschinéitic phobail Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Soláthrófar tuarascálacha maidir le staidéir ar chógaschinéitic agus infhulaingt thosaigh daoine sláintiúla agus othar, tuarascálacha maidir le staidéir chógaschinéiteacha chun measúnú a dhéanamh ar éifeachtaí tosca intreacha agus eistreacha, agus tuarascálacha maidir le staidéir ar chógaschinéitic phobail.' Reference "Togra le haghaidh Treoir maidir le Cód an Aontais a bhaineann le táirgí íocshláinte lena n‑úsáid ag an duine, agus lena n‑aisghairtear Treoir 2001/83/CE agus Treoir 2009/35/CE, CELEX:52023PC0192/GA"
    population pharmaco-kinetic study | population pharmacokinetics | population pharmaco-kinetics study | popPK | population pharmacokinetic analysis | population PK study
    en
    Definition study of variability in drug concentrations within a specific population receiving clinically relevant doses of a drug of interest Reference "COM-Terminology Coordination, based on: - Allucent. 'What is Population Pharmacokinetic (popPK) Analysis?' (22.2.2023) December 5, 2018 Content updated on July 07, 2021- 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 PopPK methods use mathematical models to describe PK data and draw conclusions. PopPK models can help guide decision-making across all phases of drug development and can also provide critical support for efficacy and safety in marketing applications such as new drug applications (NDAs) and biologics license applications (BLAs).