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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2025, Vol. 30 ›› Issue (2): 244-250.doi: 10.12092/j.issn.1009-2501.2025.02.012

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Characteristics and applications in bioequivalence of physiologically based on pharmacokinetic model

WANG Jianxiong, HU Xiao, MIAO Beibei, ZHANG Lan   

  1. Department of Pharmacology, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing Engineering Research Center for Nerve System Drugs, Beijing Institute of Brain Disorders, Key Laboratory of Neurodegenerative Diseases, Ministry of Education, Beijing 100053, China
  • Received:2024-02-01 Revised:2024-08-30 Online:2025-02-26 Published:2025-02-05

Abstract:

Physiologically based pharmacokinetics (PBPK) model is a tool to simulate the process of drug absorption, distribution, metabolism and excretion in vivo. It is widely used in drug research and regulation. In the bioequivalence evaluation of generic drug consistency evaluation and drug production process change,the PBPK model can provide a certain reference and theoretical support for the drug bioequivalence, thereby promoting safer and more economic drug clinical trials. In this paper, the application progress of PBPK model in bioequivalence study will be reviewed in order to provide support for clinical research on drugs in China.

Key words: PBPK model, bioequivalence, biopharmaceutics classification system, generic drug consistency evaluation, PBBM model

CLC Number: