Peer-Reviewed Publication
Sci Rep2021;11(1):6403.March 18, 2021Journal Article
Performance of preclinical models in predicting drug-induced liver injury in humans: a systematic review.
Hubert Dirven1, Gunn E Vist2, Sricharan Bandhakavi3, Jyotsna Mehta4, Seneca E Fitch5, Pandora Pound6, Rebecca Ram6, Breanne Kincaid7, Cathalijn H C Leenaars8, Minjun Chen9, Robert A Wright10, Katya Tsaioun11
1Department of Environmental Health, Norwegian Institute of Public Health, Oslo, Norway.
2Division for Health Services, Norwegian Institute of Public Health, Oslo, Norway.
3Geneia LLC, Cambridge, MA, USA.
4Keva Health, Lexington, MA, USA.
5ToxStrategies, Inc, Katy, TX, USA.
6Safer Medicines Trust, Kingsbridge, UK.
7Department of Environmental Health and Engineering, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
8Institute for Laboratory Animal Sciences, Hannover Medical School, Hannover, Germany.
9Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US Food and Drug Administration, Little Rock, AK, USA.
10Basic Science Informationist, Welch Medical Library, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
11Evidence-Based Toxicology Collaboration, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD, 21205, USA. ktsaiou1@jhu.edu.
Abstract
Drug-induced liver injury (DILI) causes one in three market withdrawals due to adverse drug reactions, causing preventable human suffering and massive financial loss. We applied evidence-based methods to investigate the role of preclinical studies in predicting human DILI using two anti-diabetic drugs from the same class, but with different toxicological profiles: troglitazone (withdrawn from US m…
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