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中国临床药理学与治疗学 ›› 2007, Vol. 12 ›› Issue (3): 334-341.

• 定量药理学 • 上一篇    下一篇

药代动力学和药效动力学中数学建模与模拟的基本原理(2)

黄晓晖1, 史军2, 李俊1, 宋国强3, 谢海棠4, 郑青山5, 孙瑞元4   

  1. 1安徽医科大学药学院, 合肥230032, 安徽;
    2Forest Laboratories, Inc., New Jersey 07311, USA;
    3安徽医科大学卫生管理学院, 合肥230032, 安徽;
    4安徽省药物临床评价中心, 芜湖241001, 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:2007-03-08 修回日期:2007-04-05 出版日期:2007-03-26 发布日期:2020-11-06
  • 作者简介:黄晓晖, 男, 博士, 副教授, 硕士生导师, 研究方向:数学药理学和临床药代动力学。Tel:13855183138 E-mail:mathdrug@sina.com

Pharmacokinetic-pharmacodynamic modeling and simulation:concepts and basic principles(2)

HUANG Xiao-hui1, SHI Jun2, LI Jun1, SONG Guo-qiang3, XIE Hai-tang4, ZHENG Qing-shan5, SUN Ruiyuan4   

  1. 1Center of Pharmacokinetics, College of Pharmacy, Anhui Medical University, Hefei 230032, Anhui, China;
    2Forest Laboratories, Inc., New York 10022, USA;
    3College of Health Administration, Anhui Medical University, Hefei 230032, Anhui, China;
    4Clinical Drug Evaluation Center of Anhui Province, Wuhu 241001, Anhui, China;
    5Center of Clinical Drug Research, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
  • Received:2007-03-08 Revised:2007-04-05 Online:2007-03-26 Published:2020-11-06

摘要: 数学建模与模拟(modeling and simulation,M&S) 是药代动力学(药动学) 与药效动力学(药效学) 中重要的定量研究方法, 在研究药物的处置和作用的机理、治疗药物监测及新药开发中发挥越来越重要的作用。但目前国内该领域的研究尚不多, 有待大力发展。另外, M&S 涉及的数学知识较多, 造成研究者阅读文献和实际应用的困难。本系列文章简要介绍M&S 的一些基本概念及重要原理, 供读者参考。本部分着重讨论模型开发过程及拟合优度标准的有关问题。

关键词: 药代动力学, 药效动力学, 数学模型, 建模与模拟, 拟合优度

Abstract: Modeling and simulation (M&S) is an important research field in pharmacokinetics and pharmacodynamics.M&S has evolved from a tool primarily applied to therapeutic drug monitoring to one that plays a significant role in drug development.Technological advances in various fields related to drug development call for more focus on ways to optimize current drug development practices.Recognition of the potential of M&S by regulatory agencies inevitably has a substantial impact on drug development.The objective of the current review is to present the some basic concepts and principles of M&S. Some case studies are presented to illustrate how M&S can facilitate knowledge management and decision making.In this article the model development process and goodness of fit criteria were discussed.

Key words: pharmacokinetics, pharmacodynamics, mathematical model, modeling and simulation, goodness of fit

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