熊去氧胆酸口服制剂人体生物等效性研究的审评考虑OA
Review considerations for the bioequivalence study of oral ursodeoxycholic acid preparations in humans
熊去氧胆酸(UDCA)是一种内源性的物质,熊去氧胆酸制剂口服给药后会形成结合的熊去氧胆酸,体内代谢较非内源性物质复杂.本文基于UDCA的药代动力学(PK)特点,总结目前UDCA制剂生物等效性(BE)研究中的技术要点,分别从试验设计、方法学验证、生物样品分析以及生物等效性结果评价等方面分析,为熊去氧胆酸制剂等内源性药物的生物等效性研究提供一定参考.
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.
苑如;宋晓;刘淑洁
国家药品监督管理局 药品审评中心,北京 100163国家药品监督管理局 药品审评中心,北京 100163国家药品监督管理局 药品审评中心,北京 100163
医药卫生
熊去氧胆酸内源性物质生物等效性基线
ursodeoxycholic acidendogenous substancesbioequivalencebaseline
《中国临床药理学杂志》 2026 (8)
1196-1200,5
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