{"product_id":"predictive-approaches-in-drug-discovery-and-development-isbn-9780470170830","title":"Predictive Approaches in Drug Discovery and Development","description":"\u003ci\u003ePractical Utility of Biomarkers in Drug Discovery and Development\u003c\/i\u003e covers all aspects of biomarker research applied to drug discovery and development and contains state-of-the-art appraisals on the practical utility of genomic, biochemical, and protein biomarkers.  Case histories and lessons from successful and unsuccessful applications of biomarkers are included along with key chapters on GLP validation, safety biomarkers and proteomics biomarkers.  Regulatory agency perspectives and initiatives both in the US and internationally are also discussed. \u003cp\u003ePreface xi\u003c\/p\u003e \u003cp\u003eAcknowledgments xiii\u003c\/p\u003e \u003cp\u003eContributors xv\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart I Biomarkers in Drug Discovery 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1 The Importance of Biomarkers in Translational Medicine 3\u003cbr\u003e \u003ci\u003eJoseph C. Fleishaker\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2 Validation of Biochemical Biomarker Assays used in Drug Discovery and Development: A Review ofChallenges and Solutions 23\u003cbr\u003e \u003ci\u003eGabriella Szekely-Klepser and Scott Fountain\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3 Proteomic Methods to Develop Protein Biomarkers 49\u003cbr\u003e \u003ci\u003eRuth A. VanBogelen and Diane Alessi\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4 Overview of Metabolomics Basics 79\u003cbr\u003e \u003ci\u003eQiuwei Xu and William H. Schaefer\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart II Clinical Application of Biomarkers 139\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5 Vascular Biomarkers and Imaging Studies 141\u003cbr\u003e \u003ci\u003eKarin Potthoff, Ulrike Fiedler, and Joachim Drevs\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6 Cardiovascular Biomarkers as Examples of Success and Failure in Predicting Safety in Humans 163\u003cbr\u003e \u003ci\u003eSimon Authier, Michael K. Pugsley, Eric Troncy, and Michael J. Curtis\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7 The Use of Molecular Imaging for Receptor Occupancy Decision Making in Drug Development 189\u003cbr\u003e \u003ci\u003eRalph Paul Maguire\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8 Biosensors for Clinical Biomarkers 203\u003cbr\u003e \u003ci\u003eSara Tombelli and Marco Mascini\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart III Regulatory Perspectives 229\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9 Regulatory Perspectives on Biomarker Development 231\u003cbr\u003e \u003ci\u003eRajanikanth Madabushi, Lawrence Lesko, and Janet Woodcock\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10 Perspectives from the European Regulatory Authorities 255\u003cbr\u003e \u003ci\u003eIan Hudson\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11 Use of Biomarker in Drug Development—Japanese Perspectives 269\u003cbr\u003e \u003ci\u003eYoshiaki Uyama, Akihiro Ishiguro, Harumasa Nakamura, and Satoshi Toyoshima\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart IV Predicting in Vivo 289\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e12 In Vitro–In Vivo Correlations of Hepatic Drug Clearance 291\u003cbr\u003e \u003ci\u003eR. Scott Obach\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13 The Potential of In Silico and In Vitro Approaches to Predict In Vivo Drug–Drug Interactions and ADMET\/TOX Properties 307\u003cbr\u003e \u003ci\u003eKenneth Bachmann and Sean Ekins\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14 In Vitro–In Vivo Correlations in Drug Discovery and Development: Concepts and Applications inToxicology 331\u003cbr\u003e \u003ci\u003eRex Denton, Kimberly Brannen, and Bruce D. Car\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15 Assessing the Potential for Induction of Cytochrome P450 Enzymes and Predicting the In Vivo Response 353\u003cbr\u003e \u003ci\u003eJiunn H. Lin\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIndex 383\u003c\/p\u003e  \u003cp\u003e“The ability to correlate in vitro and in vivo biomarker information in the process of drug discovery and development lies at the heart of translational research. The goal is to rapidly translate basic discoveries into clinical applications. This book provides state-of-the-art information on this exciting new research approach.”  (\u003ci\u003eDoody’s\u003c\/i\u003e, 8 February 2013)\u003c\/p\u003e \u003cp\u003e“The text is packed with interesting, comprehensive, and pertinent information, clearly presented with salient points reinforced by inclusion in text boxes . . . This is an admirable textbook for those dealing with drug discovery and development. I enjoyed reading through it and I would recommend it to anyone who has an interest, or is developing an interest, in the field of biomarkers and their, as yet, unfulfilled potential.”  (\u003ci\u003eISSX International Society for the Study of Xenobiotics\u003c\/i\u003e, 1 December 2012)\u003c\/p\u003e  \u003cp\u003eJ. Andrew Williams, PHD, is Director of Translational Oncology at Pfizer Oncology.\u003c\/p\u003e \u003cp\u003eRichard Lalonde, PharmD, is Vice President and Global Head of Clinical Pharmacology at Pfizer.\u003c\/p\u003e \u003cp\u003eJeffrey Koup, PharmD, is a consultant for PKPD modeling and the owner of Lakeside PKPD, LLC.\u003c\/p\u003e \u003cp\u003eDavid D. Christ, PHD, is a consultant with SNC Partners LLC.\u003c\/p\u003e  \u003cp\u003eComprehensive coverage of biomarker research applied to drug discovery and development\u003c\/p\u003e \u003cp\u003eTwo key factors have emerged in the race to discover approvable new drugs faster and with fewer resources: biomarkers and in vitro\/in vivo correlations (IVIVC). Predictive Approaches in Drug Discovery and Development: Biomarkers and In Vitro\/In Vivo Correlations provides comprehensive coverage of how these factors are enhancing the drug pipeline and accelerating development.\u003c\/p\u003e \u003cp\u003eAn invaluable resource, the book presents essential information on the importance of biomarkers in translational medicine, the clinical applications of biomarkers, relevant regulatory perspectives, and the potential of in vivo research. With each chapter written by one or more expert authors from the global front lines of the pharmaceutical industry and regulatory agencies, the book also incorporates academic research that unites these two fields and describes their applications, from technical lab experiments to strategic management.\u003c\/p\u003e \u003cp\u003eCovering many aspects of biomarker research as applied to drug discovery and development, the book brings together state-of-the-art appraisals of the practical utility of \"-omics\", biochemical, and protein biomarkers with case histories and lessons from successful and unsuccessful real-world applications. Regulatory agency perspectives and initiatives in the United States and around the world are also discussed, as are GLP validation and, safety biomarkers, and proteomic biomarkers.\u003c\/p\u003e \u003cp\u003eBiomarkers and IVIVC present unique opportunities for identifying more robust clinical candidates and selecting leads more intelligently, making Predictive Approaches in Drug Discovery and Development a must-have for researchers and professionals in the pharmaceutical and biotechnology industries, as well as for use in advanced graduate and undergraduate courses.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989840478437,"sku":"NP9780470170830","price":167.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780470170830.jpg?v=1761785643","url":"https:\/\/k12savings.com\/products\/predictive-approaches-in-drug-discovery-and-development-isbn-9780470170830","provider":"K12savings","version":"1.0","type":"link"}