新药研发中定量药理学研究的价值及其一般考虑

doi:10.12092/j.issn.1009-2501.2018.09.001

摘要/Abstract

摘要：

定量药理学是利用建模与模拟技术对药代动力学、药效动力学、机体功能、疾病进程和试验过程等信息进行模型化研究的一门科学。其在新药研发中的早期介入和全程参与能够形成模型引导的药物研发模式，以提高研发和科学审评效率，降低研发成本，缩短新药上市时间。本文根据国内外应用实践，阐述了定量药理学在新药研发中的价值、研究特点、应用条件及操作规范，以期作为国内定量药理学研究的专家共识，为定量药理学在我国新药研发中的应用提供参考。

关键词: 新药研发, 定量药理学研究, 专家共识

Abstract:

Pharmacometrics is a discipline to quantitatively investigate information, such as pharmacokinetics, pharmacodynamics, physiology, disease progression, and clinical trial, to produce knowledge using modeling and simulation methods. It supports new drug development since early phase in a life cycle, which forms a model-informed drug development mode to improve efficiency of drug development and regulatory administration, save development costs, and accelerate approval of new drug.This article illustrates the values and investigates the properties, application assumptions, and standard operation procedures of pharmacometrics during new drug development based on consensus of experts in domestic and overseas. We hope this white paper could standardize and improve the application of pharmacometrics in new drug development in China.

Key words: new drug development, pharmacometric study, expert consensus

中图分类号:

R965

刘东阳，王鲲，马广立，相小强，刘江，赵平，陈锐，陈渊成，黄晓晖，李丽，李禄金，聂晶，王玉珠，魏春敏，卢炜，史军，李改玲，郑青山. 新药研发中定量药理学研究的价值及其一般考虑[J]. 中国临床药理学与治疗学, doi: 10.12092/j.issn.1009-2501.2018.09.001.

LIU Dongyang,WANG Kun,MA Guangli,XIANG Xiaoqiang,LIU Jiang,ZHAO Ping,CHEN Rui,CHEN Yuancheng,HUANG Xiaohui, LI Li,LI Lujin,NIE Jing,WANG Yuzhu,WEI Chunmin,LU Wei,SHI Jun, ZHENG Qingshan. The value and general consideration of pharmacometric study in new drug development[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, doi: 10.12092/j.issn.1009-2501.2018.09.001.

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