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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.

DOI:10.1053/j.gastro.2021.10.051
PMID:34822801
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9683540/
Abstract
摘要

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Hepatology. 2022 May;75(5):1235-1246. doi: 10.1002/hep.32204. Epub 2022 Feb 7.
2
Limitations of current liver donor allocation systems and the impact of newer indications for liver transplantation.当前肝脏供体分配系统的局限性以及肝脏移植新适应症的影响。
J Hepatol. 2021 Jul;75 Suppl 1:S178-S190. doi: 10.1016/j.jhep.2021.01.007.
3
Clinical utility of 30% relative decline in MRI-PDFF in predicting fibrosis regression in non-alcoholic fatty liver disease.MRI-PDFF 下降 30%对预测非酒精性脂肪性肝病纤维化消退的临床效用。
Gut. 2022 May;71(5):983-990. doi: 10.1136/gutjnl-2021-324264. Epub 2021 Apr 21.
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Prospective evaluation of the prevalence of non-alcoholic fatty liver disease and steatohepatitis in a large middle-aged US cohort.前瞻性评估大型美国中年队列中非酒精性脂肪性肝病和脂肪性肝炎的患病率。
J Hepatol. 2021 Aug;75(2):284-291. doi: 10.1016/j.jhep.2021.02.034. Epub 2021 Mar 18.
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Gastroenterology. 2021 Apr;160(5):1608-1619.e13. doi: 10.1053/j.gastro.2020.12.003. Epub 2020 Dec 8.
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Suboptimal reliability of liver biopsy evaluation has implications for randomized clinical trials.肝活检评估的可靠性欠佳对随机临床试验有影响。
J Hepatol. 2020 Dec;73(6):1322-1332. doi: 10.1016/j.jhep.2020.06.025. Epub 2020 Jun 28.
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Advances in non-invasive assessment of hepatic fibrosis.肝纤维化无创评估的进展。
Gut. 2020 Jul;69(7):1343-1352. doi: 10.1136/gutjnl-2018-317593. Epub 2020 Feb 17.
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J Gastroenterol. 2019 Jan;54(1):87-95. doi: 10.1007/s00535-018-1503-x. Epub 2018 Sep 10.