Baseline Parameters in Clinical Trials for Nonalcoholic Steatohepatitis: Recommendations From the Liver Forum.
作者信息
Patel Yuval A, Imperial Joanne C, Muir Andrew J, Anstee Quentin M, DeBrota David, Dimick-Santos Lara, Filozof Claudia, Mehta Ruby, Sanyal Arun J, Schabel Elmer, Neuschwander-Tetri Brent A, Miller Veronica
机构信息
Duke University School of Medicine, Durham, North Carolina.
Conatus Pharmaceuticals, San Diego, California.
出版信息
Gastroenterology. 2017 Sep;153(3):621-625.e7. doi: 10.1053/j.gastro.2017.07.024. Epub 2017 Jul 27.
Abstract
摘要
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本文引用的文献
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Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science.非酒精性脂肪性肝炎临床试验终点纳入和分析的定义：从监管科学的角度。
Hepatology. 2018 May;67(5):2001-2012. doi: 10.1002/hep.29607. Epub 2018 Feb 22.
2
Nonalcoholic fatty liver disease.非酒精性脂肪性肝病。
Nat Rev Dis Primers. 2015 Dec 17;1:15080. doi: 10.1038/nrdp.2015.80.
3
Genetic Factors That Affect Risk of Alcoholic and Nonalcoholic Fatty Liver Disease.遗传因素对酒精性和非酒精性脂肪性肝病风险的影响。
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Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.
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Prevalence of nonalcoholic fatty liver disease in the United States: the Third National Health and Nutrition Examination Survey, 1988-1994.非酒精性脂肪性肝病在美国的流行情况：第三次国家健康和营养检查调查，1988-1994 年。
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