中国临床药理学杂志2026，Vol.42Issue(8)：1196-1200,5.DOI:10.13699/j.cnki.1001-6821.2026.08.023
熊去氧胆酸口服制剂人体生物等效性研究的审评考虑
Review considerations for the bioequivalence study of oral ursodeoxycholic acid preparations in humans
苑如 1宋晓 1刘淑洁1
作者信息
- 1. 国家药品监督管理局 药品审评中心,北京 100163
- 折叠
摘要
Abstract
Ursodeoxycholic acid(UDCA)is an endogenous substance.After oral administration of UDCA preparations,conjugated UDCA is formed,and its metabolism in the body is more complex than that of exogenous substances.This article based on the pharmacokinetic(PK)characteristics of UDCA,summarized the technical key points in the current bioequivalence(BE)studies of UDCA preparations.It analyzed from various aspects,including trial design,methodological validation,biological sample analysis,and bioequivalence result evaluation.This provides a certain reference for the bioequivalence studies of endogenous drugs such as ursodeoxycholic acid preparations.关键词
熊去氧胆酸/内源性物质/生物等效性/基线Key words
ursodeoxycholic acid/endogenous substances/bioequivalence/baseline分类
医药卫生引用本文复制引用
苑如,宋晓,刘淑洁..熊去氧胆酸口服制剂人体生物等效性研究的审评考虑[J].中国临床药理学杂志,2026,42(8):1196-1200,5.
