浅析MIDD在抗肿瘤药物临床研究中的应用  

Application of MIDD in Clinical Research of Antitumor Drugs

作　　者：余孟洋 王洪允 Mengyang YU;Hongyun(WANG Clinical Pharmacology Research Center,Peking Union Medical College Hospital,Peking Union Medical College and Chinese Academy of Medical Sciences,Beijing 100730,China)

机构地区：[1]中国医学科学院北京协和医学院,北京协和医院,临床药理研究中心,北京100730

出　　处：《中国肺癌杂志》2022年第7期487-492,共6页Chinese Journal of Lung Cancer

基　　金：首都卫生发展科研专项项目(首发No.2022-2Z-4018)资助。

摘　　要：抗肿瘤药物是新药研发的热点方向,其临床研究具有研发周期长、研发成本和风险高的特点。模型引导的药物开发(model-informed drug development,MIDD)通过建模与模拟,能够对生理学、药理学以及疾病进程等信息进行整合和定量分析,降低药物研发成本,提高临床研究效率。本文以奥希替尼和帕博利珠单抗为例,以问题为导向,阐述MIDD在抗肿瘤药物临床研究各个阶段的具体应用,旨在为MIDD指导抗肿瘤临药物床研究提供一定的借鉴和参考。The antitumor drug has become one of the focused areas in new drug research and development.Their clinical research generally consumes a long period of time,with high cost and high risk.Model-informed drug development(MIDD)integrates and quantitatively analyzes physiological,pharmacological,and disease progression information through modeling and simulation,which can reduce the cost of drug development and improve the efficiency of clinical research.In this essay,Osimertinib and Pembrolizumab are given as examples to illustrate the specific application of MIDD in different phases of clinical research,aiming to provide references for the application of MIDD to guide the clinical research of antitumor drugs.

关 键 词：模型引导的药物开发 暴露量-效应关系 群体药代动力学 奥希替尼 帕博利珠单抗 

分 类 号：R979.1[医药卫生—药品]