Drug-Induced Liver Toxicity

ISBN-13: 9781493976768 / Angielski / Twarda / 2018 / 667 str.

Minjun Chen; Yvonne Will

Opis

This book provides a comprehensive view of the methodologies used for the study of liver toxicity encountered throughout the whole life cycle of a drug, from drug discovery, to clinical trial, post-marketing, and even clinical practice.

Spis treści

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

Blurb

This book provides a comprehensive view of the methodologies used for the study of liver toxicity encountered throughout the whole life cycle of a drug, from drug discovery, to clinical trial, post-marketing, and even clinical practice. Organized into six sections, the first section introduces the mechanisms contributing to drug-induced liver toxicity.  The second and third section explore in silico and in vitro approaches used to help mitigate hepatotoxicity liability at the early stages of drug development. The fourth section describes methodologies applied in regulatory processes, including preclinical studies, clinical trials, and post-marketing surveillance. The fifth section discusses clinical hepatotoxicity. Emerging technologies are examined in the final section. As a volume in the Methods in Pharmacology and Toxicology series, chapters include the kind of expert advice that will lead to optimal results. 

Authoritative and practical, Drug-Induced Liver Toxicity serves all those who aim to improve assessment and understanding of hepatotoxic potentials of new medications and marketed drugs.

Chapter 30 is open access under a CC BY 4.0 license via link.springer.com.