Part I. Specific Areas of Predictive Toxicology: 1. The human predictive value of combined animal toxicity testing: current state and emerging approaches Harry M. Olson and Thomas S. Davies; 2. Screening approaches for genetic toxicity Jiri Aubrecht; 3. Cardiac safety Martin Traebert and Berengere Dumotier; 4. Predicting drug-induced liver injury: safer patients or safer drugs? Jinghai James Xu; 5. In vitro evaluation of metabolic drug-drug interactions Albert P. Li; 6. Reliability of reactive metabolite and covalent binding assessments in prediction of idiosyncratic drug toxicity Amit S. Kalgutkar; 7. Immunotoxicology of haptens and nucleic acids Jörg Vollmer; 8. Predictive models for neurotoxicity assessment Lucio G. Costa, Gennaro Giordano and Marina Guizzetti; 9. De-risking developmental toxicity-mediated drug attrition in the pharmaceutical industry Terence R. S. Ozolins; Part II. Integrated Approaches of Predictive Toxicology: 10. Integrated approaches to lead optimization: improving the therapeutic index Laszlo Urban, Jianling Wang, Dejan Bojanic and Susan Ward; 11. Predictive toxicology approaches for oncology drugs Timothy J. Maziasz, Vivek J. Kadambi and Carl L. Alden; 12. Mechanism-based toxicity studies for drug development Monicah A. Otieno and Lois D. Lehman-McKeeman; 13. Fish embryos as alternative models for drug safety evaluation Stefan Scholz, Anita Büttner, Nils Klüver and Joaquin Guinea; 14. The role of genetic-modified mouse models in predictive toxicology Glenn H. Cantor; 15. Toxicogenomic and pathway analysis Bin Lu; 16. Drug safety biomarkers David Gerhold and Frank D. Sistare; 17. Application of TK/PD modeling in predicting dose-limiting toxicity Li J. Yu, Lee Silverman, Carl Alden, Guohui Liu, Shimoga Prakash and Frank Lee; 18. Prediction of therapeutic index of antibody-based therapeutics: mathematical modeling approaches Kapil Mayawala and Bruce Gomes; 19. Vaccine toxicology: non-clinical predictive strategies Sarah Gould and Raymond Oomen.