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

Author: Binjie ZHENG ¹ ; Na LIU ¹ ; Xiangchang ZENG ¹ ; Xinyi HUANG ¹ ; Dongsheng OU-YANG ¹ ; Binjie ZHENG ² ; Na LIU ² ; Xiangchang ZENG ² ; Xinyi HUANG ² ; Dongsheng OU-YANG ² ; Lulu CHEN ³ ; Dongsheng OU-YANG ³
Author Information

1. Department of Clinical Pharmacology, Xiangya Hospital, Central South University
2. Institute of Clinical Pharmacology, Central South University, Hunan Key Laboratory of Pharmacogenetics
3. Hunan Key Laboratory for Bioanalysis of Complex Matrix Samples
Publication Type:Journal Article
Keywords: Bioequivalence; Consistency evaluation; Gut microbiota; Pharmacokinetics
From: Chinese Journal of Clinical Pharmacology and Therapeutics 2021;26(6):662-671
CountryChina
Language:Chinese
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.