Practical Utility of Biomarkers in Drug Discovery and Development 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.

Preface xiAcknowledgments xiiiContributors xvPart I Biomarkers in Drug Discovery 11 The Importance of Biomarkers in Translational Medicine 3Joseph C. Fleishaker2 Validation of Biochemical Biomarker Assays used in Drug Discovery and Development: A Review ofChallenges and Solutions 23Gabriella Szekely-Klepser and Scott Fountain3 Proteomic Methods to Develop Protein Biomarkers 49Ruth A. VanBogelen and Diane Alessi4 Overview of Metabolomics Basics 79Qiuwei Xu and William H. SchaeferPart II Clinical Application of Biomarkers 1395 Vascular Biomarkers and Imaging Studies 141Karin Potthoff, Ulrike Fiedler, and Joachim Drevs6 Cardiovascular Biomarkers as Examples of Success and Failure in Predicting Safety in Humans 163Simon Authier, Michael K. Pugsley, Eric Troncy, and Michael J. Curtis7 The Use of Molecular Imaging for Receptor Occupancy Decision Making in Drug Development 189Ralph Paul Maguire8 Biosensors for Clinical Biomarkers 203Sara Tombelli and Marco MasciniPart III Regulatory Perspectives 2299 Regulatory Perspectives on Biomarker Development 231Rajanikanth Madabushi, Lawrence Lesko, and Janet Woodcock10 Perspectives from the European Regulatory Authorities 255Ian Hudson11 Use of Biomarker in Drug Development--Japanese Perspectives 269Yoshiaki Uyama, Akihiro Ishiguro, Harumasa Nakamura, and Satoshi ToyoshimaPart IV Predicting in Vivo 28912 In Vitro-In Vivo Correlations of Hepatic Drug Clearance 291R. Scott Obach13 The Potential of In Silico and In Vitro Approaches to Predict In Vivo Drug-Drug Interactions and ADMET/TOX Properties 307Kenneth Bachmann and Sean Ekins14 In Vitro-In Vivo Correlations in Drug Discovery and Development: Concepts and Applications inToxicology 331Rex Denton, Kimberly Brannen, and Bruce D. Car15 Assessing the Potential for Induction of Cytochrome P450 Enzymes and Predicting the In Vivo Response 353Jiunn H. LinIndex 383