Drug discovery toxicology : from target assessment to translational biomarkers / edited by Yvonne Will, J. Eric McDuffie, Andrew J. Olaharski, Brandon D. Jeffy.

Includes bibliographical references and index.

Part IX. Best practices in biomarker evaluations -- 40.Best practices in preclincal biomarker sample collections. Jaqueline Tarrant -- 41.Best practices in novel biomarket assay fit-for-purpose testing. Karen M. Lynch -- 42.Best practices in evaluating novel biomarkers fit for purpose and translatability. Amanda F. Baker -- 43.Best practices in translational biomarker data analysis. Robin Mogg and Daniel Holder -- 44.Translatable biomarkers in drug development: regulatory acceptance and qualification. John-Michaeal Sauer, Elizabeth G. Walker and Amy C. Porter -- Part X.Conclusions -- 45.Toxicogenomics in drug discovery toxicology: histgory, methods, case studies, and future directions. Brandon D. Jeffs, Joseph Milano and Richard J. Brennan -- 46.Issue investigation and practices in discovery technology. Dolores Diaz, Dylan P. Hartley and Raymond Kemper.

Part I.Introduction -- 1.Emerging technologies and their roel in regulatory review. Thomas J. Colatsky -- Part II.Safety lead optimization strategies. Donna M. Dombach-- 3.Safety assessment strategies and predictive safety of biopharmaceutical and antibody drug conjugates. Michell J. Horner, Jane Hinrichs and Nicholas Bass -- 4.Discovery and development strategies for small interfering RNAs, Scott A. Barros and Gregory Hinkle -- Part III.Basis for In vitro-in vivo PK translation -- 6.The need for human exposure projection in the interpretation of preclinical in vitro and in vivo ADME tox data. Patrick Poulin --- 7.ADME properties leading to toxicity. Katya Tsaioun -- Part IV.Predicting organ toxicity -- 8.Liver. J. Gerry Kenna. Mikale Persson, Scott Q. Siler, Ke Yu, Chuchu Hu, Minjun Chen, Joshua Xu, Weida Tong, Yvonne Will and Michael D. Aleo -- 9.Cardiac -- 10.Predictive In vitro models for assessment of nephrotoxicity and drug-drug interactions in vitro. Lawrence H. Lash -- 11.Predicting organ toxicity in vitro: bone marrow. Ivan Rich and Andrew J, Olaharski -- 12.Predicting organ toxicity in vitro: dermal toxicity. Patrick J. Hayden, MIchael Bachelor. Mitchell Klausner and Helena Kanda�raova� -- 13.In vitro methods in immuniotoxicity assessment. Xu Zhu and Ellen Evans -- 14.Strategies and assays for minimizing risk of ocular toxicity during early development of systemically administered drugs. Chris J. Somps, Paul Butler, Jay H,. Fortneer, Kerrie E. Cannon and Wenhu Huang -- 15.Predciting organ toxicity in vivo - central nervous system. Greet Teuns and Alison Easter -- 16.Biomarkers, cell models, and in vitro assays for gastrointestinal toxicology. Allison Vitsky and GFina M. Yanochko -- 17.Preclinical safey assessment of drug candidate-induced pancreatic toxicity: from an applied perspective. Karrie A. Brenneman, Shashi K. Ramaiah and Lauren M. Gauthier -- Part V.Addressing the false negative space - increasing predicitivity -- 18.Animal modesl of disease for future toxicity predictions. Sherry J. Morgan and Chandikumar S. Elangbam -- 19.The use of genetically modified animals in discovery toxicology. Dolores Diaz and Jonathan M. Maher.

20.Mouse population-based toxicology for personalized medicine and improved safety prediction. Alison H. Harrill -- Part IV.Stem cells in toxicology -- 21.Applicaiton of pluripotent stem cells in drug-induced liver injury safety assessment. Christopher S. Pridgeon. Fang Zhang, James A. Heslop, Charlotte M. L. Nugues, Neil R. Kitterinham, B. Kevin Park and Christopher E. P. Goldring -- 22.Human pluriopotent stem cell-derived cardiomyocytes: a new paradigm in predictive pharmacology and toxicology. Praveen Shykla, Priyanka Garg and Joseph C. Wu -- 23.Stem cell-derived renal cells and predictive renal in vitro models. Jacqueline Kai Chin Chuah, Yue Ning Lam, Peng Huang and Daniele Zink -- Part VII.Current status of preclinical in vivo toxicity biomarkers -- 24.Predictive cardiac hypertrophy biomarkers in nonclinical studies. Steven K. Engle -- 25.Vascular injury biomarkers. Tanja S. Zabka and Kai�dre Bendjama -- 26.Novel translational biomarkers of skeletal muscle injury. Peter M. Burch and Warren E. Glaab -- 27.Translational mechanistic biomarkers and models for predicting drug-induced liver injury: clinical to in vitro perspectives. Daniel J. Antoine -- Part VIII.Kidney injury biomarkers -- 28.Assessing and predicting drug-induced kidney injury, functional change, and safety in preclinical studies in rats. Yafei Chen -- 29.Canine kidney safety protein biomarkers. Manish Sonee -- 30.Traditional kidney safety protein biomarkers and next-generation drug-induced kidney injury biomarkers in nonhuman primates.Jean-Charles Gautier and Xiaobing Zhou -- 31.Rat kidney MicroRNA atlas. Aaron T. Smith -- 32.MicroRNAs as next-generation kidney tubular injury biomarkers in rats. Heidrun Ellinger-Zeigelabuer and Rounak Nassipour -- 33.MicroRNAs as novel glomerular injury biomarkers in rats. Rachel Church -- 34.Integrating novel imaging technologies to investigate drug-induced kidney toxicity. Bettina Wilm and Neal C. Burton -- 35.In vitro to in vivo relationships with respect to kidney safety biomarkers. Paul Jenning s-- 36.Case study: Fully automated image analysis of podocyte injury biomarker expression in rats. Jing Ying Ma -- 38.Case Study: MicroRNAs as novel kidney injury biomarkers in canines. Craig Fisher, Erik Koening and Patrick Kirby -- 39.Novel testicular injury biomarkers. Hank Lin.

As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods applied at each stage of the pre-clinical drug discovery development process.