Characteristics and applications in bioequivalence of physiologically based on pharmacokinetic model
10.12092/j.issn.1009-2501.2025.02.012
- VernacularTitle:PBPK模型及其在生物等效性研究中的应用进展
- Author:
Jianxiong WANG
1
;
Xiao HU
1
;
Beibei MIAO
1
;
Lan ZHANG
1
Author Information
1. 首都医科大学宣武医院药学部;国家老年疾病临床研究中心;北京市神经药物工程技术研究中心;北京脑重大疾病研究院;神经变性病教育部重点实验室,北京 100053
- Publication Type:Journal Article
- Keywords:
PBPK model;
bioequivalence;
bio-pharmaceutics classification system;
generic drug consistency evaluation;
PBBM model
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2025;30(2):244-250
- CountryChina
- Language:Chinese
-
Abstract:
Physiologically based pharmacokinet-ics(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 pro-duction process change,the PBPK model can pro-vide a certain reference and theoretical support for the drug bioequivalence,thereby promoting safer and more economic drug clinical trials.In this pa-per,the application progress of PBPK model in bio-equivalence study will be reviewed in order to pro-vide support for clinical research on drugs in China.
