群体药代动力学/药效学模型在抗肿瘤药物临床研究中的应用进展  

Application progress of population pharmacokenitics/pharmacodymanics modeling in clinical development of anti-cancer drugs

作　　者：黄洁华 王思怡 管宴萍 姜福林 李苏[2] 黄民[1] 钟国平[1] HUANG Jie-hua;WANG Si-yi;GUAN Yan-ping;JIANG Fu-lin;LI Su;HUANG Min;ZHONG Guo-ping(Data Management Center,Institute of Clinical Pharmacology,School of Pharmaceutical Sciences,Sun Yat-Sen University,Guangzhou 510080,Guangdong Province,China;Sun Yat-sen University Cancer Center,Guangzhou 510060,Guangdong Province,China)

机构地区：[1]中山大学药学院临床药理研究所数据管理中心,广东广州510080 [2]中山大学肿瘤防治中心,广东广州510060

出　　处：《中国临床药理学杂志》2019年第22期2930-2933,2947,共5页The Chinese Journal of Clinical Pharmacology

基　　金：国家科技部科技重大专项(重大新药创制)基金资助项目(2018ZX09734-003);广东省科技发展专项资金(广东省科学技术厅)基金资助项目(2016A040403047)

摘　　要：定量药理学在抗肿瘤药物临床研究中的应用愈来愈广泛。通过建模与模拟技术确定暴露-效应-疾病进程的定量关系,预测不同给药方案下药物的暴露量、疗效以及药物不良反应,从而提高研发效率和科学决策水平。目前关于抗肿瘤药物最常用的定量药理学方法为群体药代动力学/药效学模型,可用于描述肿瘤大小、生物标志物、药物不良反应指标的动态变化或预测患者生存期长短,本文就此类模型的研究进展及应用进行综述。Objective The application of pharmacometrics in clinical development of anti-cancer agents is becoming more and more extensive.Modeling and simulation methods can help to determine the quantitative relationship among drug exposure,effect and disease process,so as to predict the drug exposure,response,and adverse effects under different dosage regimens.It aids efficient drug development,regulatory decisions and rational drug treatment.As the most frequently used pharmacometrics approach in oncology,population pharmacokenitics/pharmacodymanics(PPK/PD)models are normally applied to describe dynamic changes of tumour size,biomarkers as well as adverse effects,and predict patient’s overall survival(OS).This review has summarized advances in PPK/PD modeling analyses for anti-cancer agents and its application.

关 键 词：定量药理学 群体药代动力学/药效学模型 抗肿瘤药物 临床研究 

分 类 号：R97[医药卫生—药品]