Details

<p>Preface xi</p> <p>Acknowledgments xiii</p> <p>Contributors xv</p> <p><b>Part I Biomarkers in Drug Discovery 1</b></p> <p>1 The Importance of Biomarkers in Translational Medicine 3<br /> <i>Joseph C. Fleishaker</i></p> <p>2 Validation of Biochemical Biomarker Assays used in Drug Discovery and Development: A Review ofChallenges and Solutions 23<br /> <i>Gabriella Szekely-Klepser and Scott Fountain</i></p> <p>3 Proteomic Methods to Develop Protein Biomarkers 49<br /> <i>Ruth A. VanBogelen and Diane Alessi</i></p> <p>4 Overview of Metabolomics Basics 79<br /> <i>Qiuwei Xu and William H. Schaefer</i></p> <p><b>Part II Clinical Application of Biomarkers 139</b></p> <p>5 Vascular Biomarkers and Imaging Studies 141<br /> <i>Karin Potthoff, Ulrike Fiedler, and Joachim Drevs</i></p> <p>6 Cardiovascular Biomarkers as Examples of Success and Failure in Predicting Safety in Humans 163<br /> <i>Simon Authier, Michael K. Pugsley, Eric Troncy, and Michael J. Curtis</i></p> <p>7 The Use of Molecular Imaging for Receptor Occupancy Decision Making in Drug Development 189<br /> <i>Ralph Paul Maguire</i></p> <p>8 Biosensors for Clinical Biomarkers 203<br /> <i>Sara Tombelli and Marco Mascini</i></p> <p><b>Part III Regulatory Perspectives 229</b></p> <p>9 Regulatory Perspectives on Biomarker Development 231<br /> <i>Rajanikanth Madabushi, Lawrence Lesko, and Janet Woodcock</i></p> <p>10 Perspectives from the European Regulatory Authorities 255<br /> <i>Ian Hudson</i></p> <p>11 Use of Biomarker in Drug Development—Japanese Perspectives 269<br /> <i>Yoshiaki Uyama, Akihiro Ishiguro, Harumasa Nakamura, and Satoshi Toyoshima</i></p> <p><b>Part IV Predicting in Vivo 289</b></p> <p>12 In Vitro–In Vivo Correlations of Hepatic Drug Clearance 291<br /> <i>R. Scott Obach</i></p> <p>13 The Potential of In Silico and In Vitro Approaches to Predict In Vivo Drug–Drug Interactions and ADMET/TOX Properties 307<br /> <i>Kenneth Bachmann and Sean Ekins</i></p> <p>14 In Vitro–In Vivo Correlations in Drug Discovery and Development: Concepts and Applications inToxicology 331<br /> <i>Rex Denton, Kimberly Brannen, and Bruce D. Car</i></p> <p>15 Assessing the Potential for Induction of Cytochrome P450 Enzymes and Predicting the In Vivo Response 353<br /> <i>Jiunn H. Lin</i></p> <p>Index 383</p>

<p>“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.”  (<i>Doody’s</i>, 8 February 2013)</p> <p>“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.”  (<i>ISSX International Society for the Study of Xenobiotics</i>, 1 December 2012)</p>

<p>J. Andrew Williams, PHD, is Director of Translational Oncology at Pfizer Oncology.</p> <p>Richard Lalonde, PharmD, is Vice President and Global Head of Clinical Pharmacology at Pfizer.</p> <p>Jeffrey Koup, PharmD, is a consultant for PKPD modeling and the owner of Lakeside PKPD, LLC.</p> <p>David D. Christ, PHD, is a consultant with SNC Partners LLC.</p>

<p>Comprehensive coverage of biomarker research applied to drug discovery and development</p> <p>Two 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.</p> <p>An 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.</p> <p>Covering 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.</p> <p>Biomarkers 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.</p>

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