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. 2016 Jun;150(8):1723-7.
doi: 10.1053/j.gastro.2016.02.044. Epub 2016 Feb 26.

Regulatory Science and Drug Approval for Alcoholic and Nonalcoholic Steatohepatitis

Arun J Sanyal  1 , Veronica Miller  2
Affiliations

Regulatory Science and Drug Approval for Alcoholic and Nonalcoholic Steatohepatitis

Arun J Sanyal et al. Gastroenterology. 2016 Jun.
No abstract available

Keywords: Alcoholic Hepatitis; Clinical Trials; Drug Approval; Drug Development; End Points; Nonalcoholic Steatohepatitis; Regulatory Science; Trial Design.

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Figures

FIGURE 1:
FIGURE 1:
Pathophysiological drivers of alcoholic hepatitis are shown. Several of these are potentially targetable for therapeutics. Alcohol impairs the integrity of the intestinal barrier leading to enhanced endotoxemia and systemic exposure to bacterial products which activate the innate immune system and sensitize hepatic macrophages. Frequently following a bout of binge drinking there is increased endotoxemia and activation of severe hepatic inflammation and cholestasis along with liver injury and cell death. The intestinal barrier function (1), cytokines (2), bile acid-related cholestatic and immune-inflammatory pathways (3), genetics and inflammasome (4), and cell death modifying pathways (5) have been or are under active clinical investigation.
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