现代定量药理学的研究进展及展望

中国临床药理学与治疗学 ›› 2009, Vol. 14 ›› Issue (6): 601-612.

• 专论 • 下一篇

现代定量药理学的研究进展及展望

黄晓晖¹, 谢海棠², 史军³, 宋建国⁴, 郑青山⁵

¹安徽医科大学药学院, 合肥 230032, 安徽;
²安徽省药物临床评价中心, 芜湖 241001, 安徽;
³Metrum Institute, Tariffville,CT 06081,USA;
⁴皖南医学院, 芜湖 241002, 安徽;
⁵上海中医药大学药物临床研究中心, 上海 201203

收稿日期:2009-06-22 修回日期:2009-07-08 出版日期:2009-06-26 发布日期:2020-10-27
作者简介:黄晓晖,男,博士,副教授,硕士生导师,研究方向为定量药理学与临床药代动力学,专长于药动学和药效学的建模与模拟,及药物评价的试验设计与统计分析。近年在国内外学术期刊上发表论文30余篇(SCI源期刊收录9篇)。参编专著《数学药理学新论》、《临床药动学理论及应用》、《现代药物代谢动力学》、《药理实验方法学》、《中药临床药理学》等十五部。目前主持国家自然科学基金、安徽省自然科学基金、安徽省优秀青年科技基金、中国博士后基金等科研项目8项。研究成果获得安徽省自然科学优秀学术论文一等奖等学术奖励。担任《中国临床药理学与治疗学》杂志编委、安徽省卫生统计专业委员会常委、安徽省医药生物技术协会理事等学术职务。Tel:13855183138 E-mail:mathdrug@sina.com
基金资助:
安徽省优秀青年科技基金(08040106813);安徽省高等学校省级教学研究项目(2007jyxm250);上海市教委重点学科项目(J50303)

Advances in quantitative pharmacology

HUANG Xiao-hui¹, XIE Hai-tang², SHI Jun³, SONG Jian-guo⁴, ZHENG Qing-shan⁵

¹School of Pharmacy, Anhui Medical University, Hefei 230032, Anhui, China;
²Clinical Drug Evaluation Center of Anhui Province, Wuhu 241001, Anhui, China;
³Metrum Institute, Tariffville, CT 06081, USA;
⁴Wannan Medical College, Wuhu 241002, Anhui, China;
⁵Center of Clinical Drug Research, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China

Received:2009-06-22 Revised:2009-07-08 Online:2009-06-26 Published:2020-10-27

摘要/Abstract

摘要： 定量药理学是运用数学和统计方法, 定量研究药理作用规律的一门分支学科, 该学科在新药研发及临床药物治疗中正在发挥愈来愈重要的作用。近年国外学界提出了基于模型的新药研发等新理念, 将定量药理学的重要性提升到了新的高度, 定量药理学正迈入一个新的时代。国内该学科已有二十多年的发展历史, 打下了良好的基础, 但较国际先进水平还有一定差距, 目前正面临着新的发展契机, 机遇与挑战并存。本文首先辨析了学科定义, 并简要回顾了国内外的学科发展简史;重点介绍了该学科的重要研究领域及热点技术, 包括群体药动学/药效学、暴露-反应(药动学-药效学)关系、临床试验模拟、新型临床试验设计、生物标记物、疾病模型和试验模型、建模与模拟的方法学等;简介了基于模型的新药研发的新理念;最后, 对该学科的国内发展前景进行了展望。

关键词: 定量药理学, 新药研发, 基于模型的新药研发, 建模与模拟

Abstract: Quantitative pharmacology, also termed as pharmacometrics, is the scientific discipline that uses mathematical and statistical methods to quantify the interactions between therapeutic drugs and patients.It increasingly plays a critical role in drug development and pharmacotherapy.Model-based drug development (MBDD)is a paradigm and a mindset which promotes the use of modeling to delineate the path and focus of drug development.The utilization of MBDD remains at an early stage in China, but it is clear that Chinese scientists embrace the discipline, and are keen to apply this methodology to drug development.In this review, we first introduce the definition and developmental history of quantitative pharmacology.Furthermore, we discuss the major areas that the present research focuses and the technological advances in the filed, such as population pharmacokinetics/pharmacodynamics, exposure-response (PK-PD)modeling, clinical trial simulation, novel clinical trial designs, biomarker, disease model, trial model, and M&S methodology.Following that, we give a brief introduction to MBDD.Finally, some challenges that pharmacometrican are currently facing, and the possible solutions are discussed.

Key words: quantitative pharmacology (pharmacometrics), drug development, model-based drug development, modeling and simulation

中图分类号:

R311

黄晓晖, 谢海棠, 史军, 宋建国, 郑青山. 现代定量药理学的研究进展及展望[J]. 中国临床药理学与治疗学, 2009, 14(6): 601-612.

HUANG Xiao-hui, XIE Hai-tang, SHI Jun, SONG Jian-guo, ZHENG Qing-shan. Advances in quantitative pharmacology[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2009, 14(6): 601-612.

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现代定量药理学的研究进展及展望

Advances in quantitative pharmacology

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