Home Journals Articles Updates About
CN
image
收藏切换
Metabolism of ursodeoxycholic acid in human raises challenges to its bioequivalence studies
收藏切换
PDF
Jin-song DING1, An-na WANG2, Liang HUANG3, Wei JIA4, Chang-xiao LIU5, Ke LAN6, *
Acta Pharmaceutica Sinica | 2020, 55(9) : 2070 - 2079
Less
收藏切换
Acta Pharmaceutica Sinica | 2020, 55(9): 2070-2079
• Reviews •
Metabolism of ursodeoxycholic acid in human raises challenges to its bioequivalence studies
Full
Jin-song DING1, An-na WANG2, Liang HUANG3, Wei JIA4, Chang-xiao LIU5, Ke LAN6, *
Affiliations
  • 1. Xiangya School of Pharmaceutical Sciences, Central South University, Changsha 410083, China
  • 2. Center for Food and Drug Inspection of National Medical Products Administration, Beijing 100044, China
  • 3. West China Second University Hospital, Sichuan University, Chengdu 610041, China
  • 4. Hong Kong Traditional Chinese Medicine Phenome Research Centre, Hong Kong Baptist University, Hong Kong, China
  • 5. State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China
  • 6. West China School of Pharmacy, Sichuan University, Chengdu 610041, China
Published: 2020-09-12 doi: 10.16438/j.0513-4870.2020-0447
Outline
收藏切换

Ursodeoxycholic acid (UDCA) is an essential drug for the treatment of cholestatic liver diseases. As the most important representative of endogenous drugs, the metabolism and disposition of UDCA in human is characterized by both host-gut microbial co-metabolism and hepato-billilary-intestinal circulation. These distinct metabolic and pharmacokinetic features have brought great challenges into the bioequivalence (BE) evaluation of UDCA generic formulations. These challenges include not only biopharmaceutical problems derived from the unique physiochemical properties of amphiphilic molecules and the large single dose, but also the drug metabolism and pharmacokinetic problems associated with endogenous metabolism, long terminal half-life, high inter-and intra-individual variations, as well as accurate determination of UDCA and its metabolites. This review summarized academic and industrial literatures about the clinical pharmacokinetics and endogenous metabolism of UDCA. Current guidelines and technical challenges of UDCA BE studies were extensively discussed. Knowledge summarized in this review is expected to provide valuable reference for the development of UDCA generic formulations.

ursodeoxycholic acid  /  bioequivalence  /  pharmacokinetics  /  bile acid  /  host-gut microbial co-metabolism
Jin-song DING, An-na WANG, Liang HUANG, Wei JIA, Chang-xiao LIU, Ke LAN. Metabolism of ursodeoxycholic acid in human raises challenges to its bioequivalence studies[J]. Acta Pharmaceutica Sinica, 2020 , 55 (9) : 2070 -2079 . DOI: 10.16438/j.0513-4870.2020-0447
Appendix
Less
Year 2020 volume 55 Issue 9
PDF
151
61
Cite this Article
BibTeX
Article Info
doi: 10.16438/j.0513-4870.2020-0447
  • Receive Date：2020-03-31
  • Online Date：2026-01-23
  • Published：2020-09-12
Article Data
Affiliations
History
  • Received：2020-03-31
  • Revised：2020-04-30
Funding
Affiliations
    1. Xiangya School of Pharmaceutical Sciences, Central South University, Changsha 410083, China
    2. Center for Food and Drug Inspection of National Medical Products Administration, Beijing 100044, China
    3. West China Second University Hospital, Sichuan University, Chengdu 610041, China
    4. Hong Kong Traditional Chinese Medicine Phenome Research Centre, Hong Kong Baptist University, Hong Kong, China
    5. State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China
    6. West China School of Pharmacy, Sichuan University, Chengdu 610041, China
References
Share
https://castjournals.cast.org.cn/joweb/yxxb/EN/10.16438/j.0513-4870.2020-0447
Share to
QR

Scan QR to access full text

Cite this article
BibTeX
Citations
表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
关闭全屏
  • BibTeX
  • EndNote
  • RefWorks
  • TxT
Links
Articles
Latest Articles
Most Read
Collections
Updates
Events
News
Multimedia
About
About Us
Contact
No. 86 Xueyuan South Road, Haidian District, Beijing
100081
010-62199257
qkjq@cast.org.cn

Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House