Consensus: guidelines: best practices for detection, assessment and management of suspected acute drug‐induced liver injury during clinical trials in patients with nonalcoholic steatohepatitis

A. Regev,M. Palmer,M. Avigan,Lara Dimick‐Santos,William R. Treem,J. Marcinak,D. Seekins,G. Krishna,F. Anania,J. Freston,J. Lewis,A. Sanyal,N. Chalasani

Published 2019 in Alimentary Pharmacology and Therapeutics

ABSTRACT

The last decade has seen a rapid growth in the number of clinical trials enrolling patients with nonalcoholic fatty liver disease and nonalcoholic steatohepatitis (NASH). Due to the underlying chronic liver disease, patients with NASH often require different approaches to the assessment and management of suspected drug‐induced liver injury (DILI) compared to patients with healthy livers. However, currently no regulatory guidelines or position papers systematically address best practices pertaining to DILI in NASH clinical trials.

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