The sophistication of modelling and simulation technologies have improved dramatically over the past decade and their applications in toxicity prediction and risk assessment are of critical importance. The integration of predictive toxicology approaches will become increasingly necessary as industrial chemicals advance and as new pharmaceuticals enter the market. In this comprehensive discussion of predictive toxicology and its applications, leading experts express their views on the technologies currently available and the potential for future developments. The book covers a wide range of topics including in silico, in vitro and in vivo approaches that are being used in the safety assessment of chemical substances. It reflects the growing and urgent need to strengthen and improve our ability to predict the safety and risks posed by industrial and pharmaceutical chemicals in humans. The reader will find extensive information on the use of current animal models used for various toxicities and target mediated toxicities. Also discussed are the recent regulatory initiatives to improve the safety assessment of chemicals. The book provides an expert and comprehensive discussion on the current status and future directions of predictive toxicology and its application. The various chapters in the book also reflect the growing need for improvements in our technologies and abilities to predict toxicities of pharmaceutical and industrial chemicals to ensure product safety and protect public health.

Alan G. E. Wilson, PhD, ATS, is currently Vice President of Drug Metabolism, Pharmacokinetics, and Toxicology and Pathology at Lexicon Pharmaceuticals. He is internationally-recognized in drug metabolism, pharmacokinetics and toxicology and has over 25 years of experience working on product discovery and development for both small molecules and biotherapeutics. He has significant hands-on experience with the regulatory and GLP requirements for the conduct of ADME, PK and safety assessment studies to support regulatory submissions and clinical studies. Prior to joining Lexicon, Dr. Wilson held senior management and leadership positions with major international pharmaceutical and life science companies. He has been involved with the approval and registration of several successful marketed products and has extensive experience working with regulatory agencies in the United States, Europe and Asia Pacific. Dr. Wilson has Board of Director and Scientific Advisory experience with several companies. He is Board Certified in Toxicology and has produced more than 120 publications. Dr. Wilson has been an invited speaker and presenter at international conferences.

Introduction and overview; computational modeling approaches: in silico tools for toxicity prediction, development of an evaluation support system for estimating repeated dose toxicity of chemicals based on chemical structure, towards a common regulatory framework for computational toxicology: current status and future perspectives, information, informatics and modeling in predictive toxicology; in vitro approaches in predicting toxicity: cellular stress and in vitro predictive toxicology, in vitro genotoxicity, cardiac toxicity prediction: to simplify, or to integrate, that is the question, in vitro approaches for determining liver specific toxicity of new drug candidates, human-based in vitro experimental systems for the assessment of human-specific adverse drug effects: scientific concepts, current applications and promising approaches, models of organ injury,mitochondrial toxicity; in vivo approaches in predicting toxicity: nonclinical models for the evaluation of mechanisms of toxicity,in vivo genetic toxicology: application to cancer risk assessment, predicting hepatic toxicity in vivo, immunotoxicity testing,reproductive toxicity,toxicity biomarkers,renal toxicity, integrative approaches to toxicity prediction, metabolism-based toxicity prediction,impact of drug transporters in the pharmacological and adverse reactions of drugs,toxicokinetics, the role of computational systems biology models in toxicity testing in the 21st century: an example with predictive multi-scale models of the liver, animal models of idiosyncratic, drug-induced liver injury