{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T16:20:11Z","timestamp":1790612411346,"version":"4.1.0"},"reference-count":128,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2022,5,27]],"date-time":"2022-05-27T00:00:00Z","timestamp":1653609600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100008426","name":"Friedrich Baur Foundation","doi-asserted-by":"publisher","award":["43\/20"],"award-info":[{"award-number":["43\/20"]}],"id":[{"id":"10.13039\/501100008426","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100008426","name":"Friedrich Baur Foundation","doi-asserted-by":"publisher","award":["821283"],"award-info":[{"award-number":["821283"]}],"id":[{"id":"10.13039\/501100008426","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Translational Safety Biomarker Pipeline (TransBioLine)","award":["43\/20"],"award-info":[{"award-number":["43\/20"]}]},{"name":"Translational Safety Biomarker Pipeline (TransBioLine)","award":["821283"],"award-info":[{"award-number":["821283"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["IJMS"],"abstract":"<jats:p>Drug-induced liver injury (DILI) is a rare but potentially severe adverse drug event, which is also a major cause of study cessation and market withdrawal during drug development. Since no acknowledged diagnostic tests are available, DILI diagnosis poses a major challenge both in clinical practice as well as in pharmacovigilance. Differentiation from other liver diseases and the identification of the causative agent in the case of polymedication are the main issues that clinicians and drug developers face in this regard. Thus, efforts have been made to establish diagnostic testing methods and biomarkers in order to safely diagnose DILI and ensure a distinguishment from alternative liver pathologies. This review provides an overview of the diagnostic methods used in differential diagnosis, especially with regards to autoimmune hepatitis (AIH) and drug-induced autoimmune hepatitis (DI-AIH), in vitro causality methods using individual blood samples, biomarkers for diagnosis and severity prediction, as well as experimental predictive models utilized in pre-clinical settings during drug development regimes.<\/jats:p>","DOI":"10.3390\/ijms23116049","type":"journal-article","created":{"date-parts":[[2022,5,28]],"date-time":"2022-05-28T01:40:45Z","timestamp":1653702045000},"page":"6049","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":59,"title":["Challenges and Future of Drug-Induced Liver Injury Research\u2014Laboratory Tests"],"prefix":"10.3390","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7077-8078","authenticated-orcid":false,"given":"Sabine","family":"Weber","sequence":"first","affiliation":[{"name":"Department of Medicine II, Liver Centre Munich, LMU Klinikum Munich, 81377 Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0440-7417","authenticated-orcid":false,"given":"Alexander L.","family":"Gerbes","sequence":"additional","affiliation":[{"name":"Department of Medicine II, Liver Centre Munich, LMU Klinikum Munich, 81377 Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,5,27]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1353","DOI":"10.1053\/j.gastro.2015.02.050","article-title":"Population-representative incidence of drug-induced acute liver failure based on an analysis of an integrated health care system","volume":"148","author":"Goldberg","year":"2015","journal-title":"Gastroenterology"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"2065","DOI":"10.1002\/hep.23937","article-title":"Drug-induced acute liver failure: Results of a U.S. multicenter, prospective study","volume":"52","author":"Reuben","year":"2010","journal-title":"Hepatology"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1154","DOI":"10.1136\/gutjnl-2016-313369","article-title":"Drug-induced liver injury: Recent advances in diagnosis and risk assessment","volume":"66","author":"Andrade","year":"2017","journal-title":"Gut"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"806","DOI":"10.1038\/clpt.2011.58","article-title":"Case definition and phenotype standardization in drug-induced liver injury","volume":"89","author":"Aithal","year":"2011","journal-title":"Clin. 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