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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2004, Vol. 9 ›› Issue (12): 1333-1337.

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Population pharmacokinetics and its application in new drug development

SHENG Yu-Cheng, ZHENG Qing-Shan   

  1. Anhui Provincial Center for Drug Clinical Evaluation, YijishanHospital, Wannan Medical College, Wuhu 241001, Anhui, China
  • Received:2004-12-16 Revised:2004-12-22 Online:2004-12-26 Published:2020-11-19

Abstract: There is an increasing focus on the application of population pharmacokinetics(PPK) in new drug development.The population PK approach can quantitative explore relationships among the pharmacokinetics, pathophysiologic features and concomitant medications. The variability of PK parameters within the population can be estimated and dosages can be appropriately modified, and this approach can increase the evaluation of safety and efficacy for the new drug.This article reviews the approach of population pharmacokinetics and its application in new drug develepment.

Key words: population pharmacokinetics, nonlinear mixed effect model, mathematical model, fixed effects, pharmacokinetics

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