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Expert Opinion on Drug Metabolism & Toxicology Volume 13, 2017 - Issue 7
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Review

Test systems in drug discovery for hazard identification and risk assessment of human drug-induced liver injury

Industry-led perspective from EFPIA members of the EU Innovative Medicines Initiative Drug Liver Injury Project, MIP DILI

Richard J. WeaverResearch & Biopharmacy, Institut de Recherches Internationales Servier, Suresnes, FranceCorrespondence[email protected]
ORCID Iconhttp://orcid.org/0000-0001-6439-6030View further author information
ORCID Icon,
Catherine BettsPathology Sciences, Drug Safety and Metabolism, AstraZeneca R&D, Cambridge, UKView further author information
,
Eric A.G. BlommePreclinical Safety, AbbVie, North Chicago, USAView further author information
,
Helga H.J. GeretsNon Clinical Development, Chemin du Foriest, UCB BioPharma SPRL, Braine L’Alleud, BelgiumView further author information
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Klaus Gjervig JensenDrug ADME Research, H. Lundbeck A/S, 9 Ottiliavej, Valby, DenmarkView further author information
,
Philip G. HewittNon-Clinical Development, Merck KGaA, Darmstadt, GermanyView further author information
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Satu JuhilaIn Vitro Biology, Orion Pharma, Espoo, FinlandView further author information
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Gilles LabbeInvestigative Toxicology, Preclinical Safety, Sanofi R&D, Paris, FranceView further author information
,
Michael J. LiguoriPreclinical Safety, AbbVie, North Chicago, USAView further author information
,
Natalie MesensPreclinical Development & Safety, Janssen (Pharmaceutical Companies of Johnson & Johnson) Turnhoutseweg 30, Beerse, BelgiumView further author information
,
Monday O. OgesePathology Sciences, Drug Safety and Metabolism, AstraZeneca R&D, Cambridge, UKView further author information
,
Mikael PerssonInnovative Medicines and Early Clinical Development, Drug Safety and Metabolism, Discovery Safety, AstraZeneca R&D, Mölndal, SwedenView further author information
,
Jan SnoeysPharmacokinetics Dynamics & Metabolism, Janssen (Pharmaceutical Companies of Johnson & Johnson) Turnhoutseweg 30, Beerse, BelgiumView further author information
,
James L. StevensDept of Toxicology, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USAView further author information
,
Tracy WalkerInvestigative Safety & Drug Metabolism, GlaxoSmithKline, David Jack Centre for Research and Development, Ware, Herts, Hertfordshire, UKView further author information
&
B. Kevin ParkInstitute of Translational Medicine, University of Liverpool, Liverpool, UKView further author information
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Pages 767-782 | Received 08 Jan 2017, Accepted 08 Jun 2017, Published online: 28 Jun 2017

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Sefa Celik, Gozde Yilmaz, Aysen E. Ozel & Sevim Akyuz. (2022) Structural and spectral analysis of anticancer active cyclo(Ala–His) dipeptide. Journal of Biomolecular Structure and Dynamics 40:2, pages 660-672.
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Lesley A. Stanley & C. Roland Wolf. (2022) Through a glass, darkly? HepaRG and HepG2 cells as models of human phase I drug metabolism. Drug Metabolism Reviews 54:1, pages 46-62.
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Articles from other publishers (26)

I. A. Mazerkina. (2023) <i>In Vitro</i> Assessment of Drug-Induced Liver Injury Using Cell-Based Models: A Review. Safety and Risk of Pharmacotherapy 11:2, pages 131-144.
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Francois Pognan, Mario Beilmann, Harrie C. M. Boonen, Andreas Czich, Gordon Dear, Philip Hewitt, Tomas Mow, Teija Oinonen, Adrian Roth, Thomas Steger-Hartmann, Jean-Pierre Valentin, Freddy Van Goethem, Richard J. Weaver & Peter Newham. (2023) The evolving role of investigative toxicology in the pharmaceutical industry. Nature Reviews Drug Discovery 22:4, pages 317-335.
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Youhao Chen, Shaoxing Guan, Yanping Guan, Siyuan Tang, Yanying Zhou, Xueding Wang, Huichang Bi & Min Huang. (2022) Novel Clinical Biomarkers for Drug-Induced Liver Injury. Drug Metabolism and Disposition 50:5, pages 671-684.
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Fabian Philipp Kreutzer, Anna Meinecke, Kevin Schmidt, Jan Fiedler & Thomas Thum. (2022) Alternative strategies in cardiac preclinical research and new clinical trial formats. Cardiovascular Research 118:3, pages 746-762.
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Christopher A. Schofield, Tracy M. Walker, Maxine A. Taylor, Metul Patel, Denise F. Vlachou, Justyna M. Macina, Martin P. Vidgeon-Hart, Ann Williams, Paul J. McGill, Carla F. Newman & Melanie Z. Sakatis. (2021) Evaluation of a Three-Dimensional Primary Human Hepatocyte Spheroid Model: Adoption and Industrialization for the Enhanced Detection of Drug-Induced Liver Injury. Chemical Research in Toxicology 34:12, pages 2485-2499.
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Antonio Segovia-Zafra, Daniel E. Di Zeo-Sánchez, Carlos López-Gómez, Zeus Pérez-Valdés, Eduardo García-Fuentes, Raúl J. Andrade, M. Isabel Lucena & Marina Villanueva-Paz. (2021) Preclinical models of idiosyncratic drug-induced liver injury (iDILI): Moving towards prediction. Acta Pharmaceutica Sinica B 11:12, pages 3685-3726.
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Zhao-Chun Chi. (2021) Research status and progress of drug induced liver injury. World Chinese Journal of Digestology 29:16, pages 915-925.
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Li Liu, Chenghong Long, Shenghui Wei & Yu Sun. (2021) Electrochemical sensor based on molecularly imprinted film for high sensitivity detection of clenbuterol prepared using sol-gel method. International Journal of Electrochemical Science 16:4, pages 210411.
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Courtney Sakolish, Celeste E. Reese, Yu-Syuan Luo, Alan Valdiviezo, Mark E. Schurdak, Albert Gough, D. Lansing Taylor, Weihsueh A. Chiu, Lawrence A. Vernetti & Ivan Rusyn. (2021) Analysis of reproducibility and robustness of a human microfluidic four-cell liver acinus microphysiology system (LAMPS). Toxicology 448, pages 152651.
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Aneesha Basharat, Helen E. Rollison, Dominic P. Williams & Delyan P. Ivanov. (2020) HepG2 (C3A) spheroids show higher sensitivity compared to HepaRG spheroids for drug-induced liver injury (DILI). Toxicology and Applied Pharmacology 408, pages 115279.
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Bryan H. Norman. (2020) Drug Induced Liver Injury (DILI). Mechanisms and Medicinal Chemistry Avoidance/Mitigation Strategies. Journal of Medicinal Chemistry 63:20, pages 11397-11419.
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Paul A. Walker, Stephanie Ryder, Andrea Lavado, Clive Dilworth & Robert J. Riley. (2020) The evolution of strategies to minimise the risk of human drug-induced liver injury (DILI) in drug discovery and development. Archives of Toxicology 94:8, pages 2559-2585.
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Radhakrishna Sura, Terry Van Vleet & Brian R. Berridge. (2020) Microphysiological Systems: A Pathologist’s Perspective. Veterinary Pathology 57:3, pages 358-368.
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John R. Foster, Giovanna Semino-Beninel & Stephanie Melching-Kollmuss. (2020) The Cumulative Risk Assessment of Hepatotoxic Chemicals: A Hepatic Histopathology Perspective. Toxicologic Pathology 48:3, pages 397-410.
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Giulio Giustarini, Suzanna Huppelschoten, Marco Barra, Angela Oppelt, Laura Wagenaar, Richard J. Weaver, Marianne Bol-Schoenmakers, Joost J. Smit, Bob van de Water, Ursula Klingmüller & Raymond H.H. Pieters. (2020) The hepatotoxic fluoroquinolone trovafloxacin disturbs TNF- and LPS-induced p65 nuclear translocation in vivo and in vitro. Toxicology and Applied Pharmacology 391, pages 114915.
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Guruprasad P. Aithal & Gerd A. Kullak‐Ublick. 2020. The Liver. The Liver 1050 1057 .
Richard J. Weaver, Eric A. Blomme, Amy E. Chadwick, Ian M. Copple, Helga H. J. Gerets, Christopher E. Goldring, Andre Guillouzo, Philip G. Hewitt, Magnus Ingelman-Sundberg, Klaus Gjervig Jensen, Satu Juhila, Ursula Klingmüller, Gilles Labbe, Michael J. Liguori, Cerys A. Lovatt, Paul Morgan, Dean J. Naisbitt, Raymond H. H. Pieters, Jan Snoeys, Bob van de Water, Dominic P. Williams & B. Kevin Park. (2019) Managing the challenge of drug-induced liver injury: a roadmap for the development and deployment of preclinical predictive models. Nature Reviews Drug Discovery 19:2, pages 131-148.
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Andreas R. Baudy, Monicah A. Otieno, Philip Hewitt, Jinping Gan, Adrian Roth, Douglas Keller, Radhakrishna Sura, Terry R. Van Vleet & William R. Proctor. (2020) Liver microphysiological systems development guidelines for safety risk assessment in the pharmaceutical industry. Lab on a Chip 20:2, pages 215-225.
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Raul J. Andrade, Naga Chalasani, Einar S. Björnsson, Ayako Suzuki, Gerd A. Kullak-Ublick, Paul B. Watkins, Harshad Devarbhavi, Michael Merz, M. Isabel Lucena, Neil Kaplowitz & Guruprasad P. Aithal. (2019) Drug-induced liver injury. Nature Reviews Disease Primers 5:1.
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Qiuwei Xu, Liping Liu, Heather Vu, Matthew Kuhls, Amy G. Aslamkhan, Andy Liaw, Yan Yu, Allen Kaczor, Michael Ruth, Christina Wei, John Imredy, Jose Lebron, Kara Pearson, Raymond Gonzalez, Kaushik Mitra & Frank D. Sistare. (2019) Can Galactose Be Converted to Glucose in HepG2 Cells? Improving the in Vitro Mitochondrial Toxicity Assay for the Assessment of Drug Induced Liver Injury . Chemical Research in Toxicology 32:8, pages 1528-1544.
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Raúl J. Andrade, Guruprasad P. Aithal, Einar S. Björnsson, Neil Kaplowitz, Gerd A. Kullak-Ublick, Dominique Larrey & Tom H. Karlsen. (2019) EASL Clinical Practice Guidelines: Drug-induced liver injury. Journal of Hepatology 70:6, pages 1222-1261.
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Julia Johansson, Marie H. Larsson & Jorrit J. Hornberg. (2019) Predictive in vitro toxicology screening to guide chemical design in drug discovery. Current Opinion in Toxicology 15, pages 99-108.
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Lydia Woelflingseder, Benedikt Warth, Immina Vierheilig, Heidi Schwartz-Zimmermann, Christian Hametner, Veronika Nagl, Barbara Novak, Bojan Šarkanj, Franz Berthiller, Gerhard Adam & Doris Marko. (2019) The Fusarium metabolite culmorin suppresses the in vitro glucuronidation of deoxynivalenol. Archives of Toxicology 93:6, pages 1729-1743.
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Richard J Weaver & Jean-Pierre Valentin. (2019) Today’s Challenges to De-Risk and Predict Drug Safety in Human “Mind-the-Gap”. Toxicological Sciences 167:2, pages 307-321.
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Alessandra Natale, Joost Boeckmans, Terry Desmae, Veerle De Boe, Joery De Kock, Tamara Vanhaecke, Vera Rogiers & Robim M. Rodrigues. (2018) Hepatic cells derived from human skin progenitors show a typical phospholipidotic response upon exposure to amiodarone. Toxicology Letters 284, pages 184-194.
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