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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2021, Vol. 26 ›› Issue (6): 662-671.doi: 10.12092/j.issn.1009-2501.2021.06.009

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Effects of gut microbiota on pharmacokinetics and its consideration in the evaluation of the consistency of quality and efficacy of generic drugs

ZHENG Binjie 1,2, LIU Na 1,2, ZENG Xiangchang 1,2, HUANG Xinyi 1,2, CHEN Lulu 3, OU-YANG Dongsheng 1,2,3   

  1. 1 Department of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha 410008, Hunan, China; 2 Institute of Clinical Pharmacology, Central South University; Hunan Key Laboratory of Pharmacogenetics, Changsha 410078, Hunan, China; 3 Hunan Key Laboratory for Bioanalysis of Complex Matrix Samples, Changsha 410000, Hunan, China 
  • Received:2020-12-17 Revised:2021-04-25 Online:2021-06-26 Published:2021-07-06

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Abstract: Generic drugs account for more than 95% of the chemicals market in China, and their quality is directly related to the efficacy and safety of the people. The bioequivalence evaluation with pharmacokinetic parameters as the end point is the main content of the consistency evaluation of the quality and efficacy of generic drugs. Gut microbiota is considered to have an important influence on pharmacokinetics. This article reviewed the influence of gut microbiota on pharmacokinetics and analyzed its potential significance in the evaluation of the consistency of quality and efficacy of generic drugs. 

Key words: gut microbiota, pharmacokinetics, bioequivalence, consistency evaluation

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