新药研发中群体药动学/药效学研究的一般考虑  

General considerations of population pharmacokinetic/pharmacodynamic study in new drug development

作　　者：马广立 许羚[2] 陈锐[3] 陈渊成[4] 赵维[5] 刘东阳 焦正 李健 季双敏 李丽 李良 王玉珠 杨进波 王亚宁 孙鹤 胡蓓[3] 郑青山[2] 卢炜[11] MA Guangli;XU Ling;CHEN Rui;CHEN Yuancheng;ZHAO Wei;LIU Dongyang;JIAO Zheng;LI Jian;JI Shuangmin;LI Li;LI Liang;WANG Yuzhu;YANG Jinbo;WANG Yaning;SUN He;HU Pei;ZHENG Qingshan;LU Wei

机构地区：[1]江苏恒瑞医药股份有限公司 [2]上海中医药大学 [3]北京协和医院 [4]复旦大学附属华山医院 [5]山东大学 [6]北京大学第三医院 [7]上海交通大学附属胸科医院 [8]NMPA药品审评中心 [9]FDA药品审评中心 [10]天士力医药集团股份有限公司 [11]北京大学药学院

出　　处：《中国临床药理学与治疗学》2019年第11期1201-1220,共20页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：群体药动学/药效学研究以及基于此之上的量效关系研究已成为新药研发与监管的工具与重要组成部分。将其有机地嵌入新药研发和评审过程中,将能够使研发和评审更为高效,并回答一些传统药动学/药效学无法回答的问题。作为专家共识,本文对群体药动学/药效学研究在新药研发与评审中的应用、试验设计、模型分析方法、分析结果的质量控制与研究报告内容进行了论述。作者们期望本文能为群体药动学/药效学研究在我国新药研发中的应用提供积极有益的参考。Population pharmacokinetic/pharmacodynamic (PopPK/PD) study and so derived exposure-response study are key components in new drug development and regulatory decision making. Integrating such studies into new drug development will facilitate new drug development and regulatory decision-making processes. As an expert consensus, this document provides the areas of applications, clinical trial designs, modeling analysis methods, quality control concerns and study reporting formats of PopPK/PD studies in new drug development/regulatory submissions. The authors expect this document can be a valuable reference to those scientists and regulatory reviewer who wish to adapt PopPK/PD studies into new drug development and drug approval processes in China.

关 键 词：新药研发 定量药理学 群体药动学 药效学 量效关系 专家共识 

分 类 号：R969.1[医药卫生—药理学]