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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2007, Vol. 12 ›› Issue (3): 334-341.

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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

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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