群体药代动力学技术在虚拟临床试验中的应用与发展趋势  

Application and development trends of population pharmacokinetic techniques in virtual clinical trials

作　　者：张玉明 刘懿贤 郑莉[1,2] ZHANG Yuming;LIU Yixian;ZHENG Li(Clinical Trial Center,West China Hospital,Sichuan University,Chengdu,610041,P.R.China;NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug,West China Hospital,Sichuan University,Chengdu,610041,P.R.China;West China School of Medicine,West China Hospital,Sichuan University,Chengdu,610041,P.R.China)

机构地区：[1]四川大学华西医院临床试验中心,成都610041 [2]四川大学华西医院,国家药品监督管理局创新药物临床研究与评价重点实验室,成都610041 [3]四川大学华西临床医学院,成都610041

出　　处：《中国胸心血管外科临床杂志》2024年第10期1400-1406,共7页Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

基　　金：四川省科技厅重大专项(2020YFS0034)。

摘　　要：群体药代动力学是基于计算机模拟和数据分析技术,用于研究不同目标人群的体内药物代谢动力学行为的研究方法。其可以改善传统药物临床试验周期长、成本高、难度大等现实问题,综合分析不同生理、病理状态下人群的体内药物代谢过程差异,成为优化药物研发和临床应用的有效技术手段。本文将对群体药代动力学的内涵、在临床试验中的应用及未来的发展趋势进行初步综述,旨在为新技术、新方法在临床试验中的应用提供参考和借鉴。Population pharmacokinetics is a research technique based on computer simulation and data analysis,and it has been employed to investigate the dynamic behavior of drug metabolism in different populations.This approach could address practical challenges such as prolonged clinical trial durations,high costs,and increased difficulty in traditional clinical trials.By comprehensively analyzing differences in the internal drug metabolism processes across populations with varying physiological and pathological conditions,population pharmacokinetics has emerged as an effective method to optimize drug development and clinical applications.This article provides a preliminary overview of the essence of population pharmacokinetics,its application in clinical trials,and potential future trends.We hope to serve as a reference and guidance for the application of new technologies and methods in clinical trials.

关 键 词：群体药代动力学 虚拟临床试验 建模与模拟 

分 类 号：R969.1[医药卫生—药理学]