Table of Contents

Front Matter.
PART I, BIOMARKERS IN DRUG DISCOVERY. The Importance of Biomarkers in Translational Medicine / Joseph C. Fleishaker.
Validation of Biochemical Biomarker Assays used in Drug Discovery and Development: A Review of Challenges and Solutions / Gabriella Szekely-Klepser and Scott Fountain.
Proteomic Methods to Develop Protein Biomarkers / Ruth A. VanBogelen and Diane Alessi.
Overview of Metabolomics Basics / Qiuwei Xu and William H. Schaefer.
PART II, CLINICAL APPLICATION OF BIOMARKERS. Vascular Biomarkers and Imaging Studies / Karin Potthoff, Ulrike Fiedler, and Joachim Drevs.
Cardiovascular Biomarkers as Examples of Success and Failure in Predicting Safety in Humans / Simon Authier, Michael K. Pugsley, Eric Troncy, and Michael J. Curtis.
The Use of Molecular Imaging for Receptor Occupancy Decision Making in Drug Development / Ralph Paul Maguire.
Biosensors for Clinical Biomarkers / Sara Tombelli and Marco Mascini.
PART III, REGULATORY PERSPECTIVES. Regulatory Perspectives on Biomarker Development / Rajanikanth Madabushi, Lawrence Lesko, and Janet Woodcock.
Perspectives from the European Regulatory Authorities / Ian Hudson.
Use of Biomarker in Drug Development : Japanese Perspectives / Yoshiaki Uyama, Akihiro Ishiguro, Harumasa Nakamura, and Satoshi Toyoshima.
PART IV, PREDICTING IN VIVO. In Vitro-In Vivo Correlations of Hepatic Drug Clearance / R. Scott Obach.
The Potential of In Silico and In Vitro Approaches to Predict In Vivo Drug-Drug Interactions and ADMET/TOX Properties / Kenneth Bachmann and Sean Ekins.
In Vitro-In Vivo Correlations in Drug Discovery and Development: Concepts and Applications in Toxicology / Rex Denton, Kimberly Brannen, and Bruce D. Car.
Assessing the Potential for Induction of Cytochrome P450 Enzymes and Predicting the In Vivo Response / Jiunn H. Lin.
Index. 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.
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.