目次

Part I: Introduction   1. Overview of Mechanisms of Drug-Induced Liver Injury (DILI) and Key Challenges in DILI Research             Nabil Noureddin and Neil Kaplowitz   Part II: In Silico and Modeling Approaches   2. Detection, Elimination, Mitigation, and Prediction of Drug-Induced Liver Injury in Drug Discovery             Francois Pognan   3. Drug-Induced Liver Injury (DILI) Classification and Its Application on Human DILI Risk Prediction             Shraddha Thakkar, Minjun Chen, Huixiao Hong, Zhichao Liu, Hong Fang, and Weida Tong   4. Physicochemical Properties and Structural Alerts             Lilia Fisk, Nigel Greene, and Russ Naven   5. Quantitative Structure-Activity Relationship Models for Predicting Risk of Drug-Induced Liver Injury in Humans             Huixiao Hong, Jieqiang Zhu, Minjun Chen, Ping Gong, Chaoyang Zhang, and Weida Tong   6. An Introduction to DILIsym® Software, a Mechanistic Mathematical Representation of Drug-Induced Liver Injury             Christina Battista, Brett A. Howell, Scott Q. Siler, and Paul B. Watkins   Part III: In Vitro Technologies   7. Prediction of Human Liver Toxicity Using In Vitro Assays: Limitations and Opportunities             Franck A. Atienzar and Jean-Marie Nicolas   8. Use of Liver-Derived Cell Lines for the Study of Drug-Induced Liver Injury             Zhen Ren, Si Chen, Baitang Ning, and Lei Guo   9. Evaluation of Drug-induced Liver Injuries (DILI) with Human Hepatocytes: Scientific Rationale and Experimental Approaches             Albert P. Li   10. Status and Use of Induced Pluripotent Stem Cells (iPSCs) in Toxicity Testing             Min Wei Wong, Chris S. Pridgeon, Constanze Schlott, B. Kevin Park, and Christopher E.P. Goldring   11. Engineered Human Liver Co-Cultures for Investigating Drug-Induced Liver Injury             Chase P. Monckton, and Salman R. Khetani   12. Status and Future of 3D Cell Culture in Toxicity Testing             Monicah A. Otieno, Jinping Gan, and William Proctor   13. Reactive Metabolite Assessment in Drug Discovery and Development in Support of Safe Drug Design             Axel Pähler   14. In Vitro Assessment of Mitochondrial Toxicity to Predict Drug-Induced Liver Injury             Mathieu Porceddu, Nelly Buron, Pierre Rustin, Bernard Fromenty, and Annie Borgne-Sanchez   15. Bile Salt Export Pump: Drug-Induced Liver Injury and Assessment Approaches             Ruitang Deng   16. High Content Screening for Prediction of Human Drug-Induced Liver Injury             Mikael Persson   17. Interpretation, Integration, and Implementation of In Vitro Assay Data: The Predictive Toxicity Challenge             Deborah S. Light, Michael D. Aleo, and J. Gerry Kenna   Part IV: Methodologies Applied in Regulatory Science   18. Perspectives on the Regulatory and Clinical Science of Drug-Induced Liver Injury (DILI)             Mark I. Avigan and Monica A. Muñoz   19. Regulatory Toxicological Studies: Identifying Drug-Induced Liver Injury Using Nonclinical Studies             Elizabeth Hausner and Imran Khan   20. Hy’s Law and eDISH for Clinical Studies             John Senior and Ted Guo   21. Variability in Baseline Liver Test Values in Clinical Trials: Challenges in Enhancing Drug-Induced Liver Injury Assessment in Subjects with Liver Disease             Bereket Tesfaldet, Gyorgy Csako, Tejas Patel, Md Shamsuzzaman, and Eileen Navarro Almario   22. Postmarketing Surveillance of Drug-Induced Liver Injury             S. Christopher Jones, Cindy Kortepeter, and Allen D. Brinker   Part V: Methodologies for Clinical Studies   23. Host Risk Modifiers in Idiosyncratic Drug-Induced Liver Injury (DILI) and Its Interplay with Drug Properties             Camilla Stephens, M. Isabel Lucena, and Raúl J. Andrade   24. Human Leukocyte Antigen (HLA) and Other Genetic Risk Factors in Drug-Induced Liver Injury (DILI)             Ann K. Daly   25. Immune Mechanisms in Drug-Induced Liver Injury             Hartmut Jaeschke and Dean J. Naisbitt   26. Translational and Mechanistic Biomarkers of Drug-Induced Liver Injury             Daniel J. Antoine   27. Causality Assessment Methods in Drug-Induced Liver Injury             Rolf Teschke and Gaby Danan   Part VI: New Emerging Technologies   28. Circulating MicroRNAs as Novel Biomarkers of Drug-Induced Liver Injury in Humans             Julian Krauskopf, Jos C. Kleinjans, and Theo M. de Kok   29. Systems Microscopy Approaches in Unraveling and Predicting Drug-Induced Liver Injury (DILI)             Marije Niemeijer, Steven Hiemstra, Steven Wink, Wouter den Hollander, Bas ter Braak, and Bob van de Water   30. Non-Invasive Pre-Clinical and Clinical Imaging of Liver Transporter Function Relevant to Drug-Induced Liver Injury             J. Gerry Kenna, John C. Waterton, Andreas Baudy, Aleksandra Galetin, Catherine D.G. Hines, Paul Hockings, Manishkumar Patel, Daniel Scotcher, Steven Sourbron, Sabina Ziemian, and Gunnar Schuetz