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Expert Panel Review to Compare FDA and EMA Guidance on Drug Development and Endpoints in Nonalcoholic Steatohepatitis.

作者信息

Loomba Rohit, Ratziu Vlad, Harrison Stephen A

机构信息

NAFLD Research Center, Division of Gastroenterology and Hepatology, Department of Medicine, University of California San Diego, La Jolla, California.

Sorbonne Université, Institute of Cardiometabolism and Nutrition, Pitié-Salpêtrière Hospital, Paris, France.

出版信息

Gastroenterology. 2022 Mar;162(3):680-688. doi: 10.1053/j.gastro.2021.10.051. Epub 2021 Nov 23.

Abstract
摘要

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Cirrhosis regression is associated with improved clinical outcomes in patients with nonalcoholic steatohepatitis.
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Suboptimal reliability of liver biopsy evaluation has implications for randomized clinical trials.
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Advances in non-invasive assessment of hepatic fibrosis.
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Changes in the Global Burden of Chronic Liver Diseases From 2012 to 2017: The Growing Impact of NAFLD.
Hepatology. 2020 Nov;72(5):1605-1616. doi: 10.1002/hep.31173. Epub 2020 Oct 27.
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Donor Small-Droplet Macrovesicular Steatosis Affects Liver Transplant Outcome in HCV-Negative Recipients.
Can J Gastroenterol Hepatol. 2019 May 2;2019:5862985. doi: 10.1155/2019/5862985. eCollection 2019.

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