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Patients with cholestatic liver disease often require different approaches to assessment and management of suspected drug\u2010induced liver injury (DILI) compared to those with healthy livers and those with parenchymal liver diseases. At present, there are no regulatory guidelines or society position papers, that systematically address best practices pertaining to detection of DILI in these patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aims<\/jats:title><jats:p>To outline best practices for detection, assessment and management of suspected acute DILI during clinical trials in adults with the cholestatic liver diseases \u2013 Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This is one of the several papers developed by the IQ DILI Initiative, which is comprised of members from 16 pharmaceutical companies, in collaboration with DILI experts from academia and regulatory agencies. The contents are the result of an extensive literature review, as well as in\u2010depth discussions among industry, regulatory and academic DILI experts, to achieve consensus recommendations on DILI\u2010related issues occurring during clinical trials for cholestatic liver diseases.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Recommended best practices are outlined pertaining to hepatic eligibility criteria, monitoring of liver tests, approach to a suspected DILI signal, and hepatic discontinuation rules.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This paper provides a framework for the approach to detection, assessment and management of suspected acute DILI occurring during clinical trials in adults with cholestatic liver disease.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.15579","type":"journal-article","created":{"date-parts":[[2019,11,25]],"date-time":"2019-11-25T08:14:23Z","timestamp":1574669663000},"page":"90-109","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Consensus guidelines: best practices for detection, assessment and management of suspected acute drug\u2010induced liver injury occurring during clinical trials in adults with chronic cholestatic liver disease"],"prefix":"10.1111","volume":"51","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8745-6865","authenticated-orcid":false,"given":"Melissa","family":"Palmer","sequence":"first","affiliation":[{"name":"Takeda Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6570-7769","authenticated-orcid":false,"given":"Arie","family":"Regev","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis IN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith","family":"Lindor","sequence":"additional","affiliation":[{"name":"Mayo Clinic Phoenix AZ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark I.","family":"Avigan","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lara","family":"Dimick\u2010Santos","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Treem","sequence":"additional","affiliation":[{"name":"Takeda Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John F.","family":"Marcinak","sequence":"additional","affiliation":[{"name":"Takeda Deerfield IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James H.","family":"Lewis","sequence":"additional","affiliation":[{"name":"Georgetown University Hospital Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank A.","family":"Anania","sequence":"additional","affiliation":[{"name":"US Food and Drug Administration Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Seekins","sequence":"additional","affiliation":[{"name":"Bristol\u2010Myers Squibb Lawrenceville NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin L.","family":"Shneider","sequence":"additional","affiliation":[{"name":"Baylor College of Medicine Houston TX USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naga","family":"Chalasani","sequence":"additional","affiliation":[{"name":"Indiana University School of Medicine Indianapolis IN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,11,25]]},"reference":[{"key":"e_1_2_21_2_1","unstructured":"International Consortium for Innovation & Quality in Pharmaceutical Development DILI (IQ DILI).Iq dili initiative.www.iqdili.org. 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