Description
Book SynopsisPractical 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.
Trade Review“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.” (Doody’s, 8 February 2013)
“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.” (ISSX International Society for the Study of Xenobiotics, 1 December 2012)
Table of ContentsPreface xi
Acknowledgments xiii
Contributors xv
Part I Biomarkers in Drug Discovery 1
1 The Importance of Biomarkers in Translational Medicine 3
Joseph C. Fleishaker
2 Validation of Biochemical Biomarker Assays used in Drug Discovery and Development: A Review ofChallenges and Solutions 23
Gabriella Szekely-Klepser and Scott Fountain
3 Proteomic Methods to Develop Protein Biomarkers 49
Ruth A. VanBogelen and Diane Alessi
4 Overview of Metabolomics Basics 79
Qiuwei Xu and William H. Schaefer
Part II Clinical Application of Biomarkers 139
5 Vascular Biomarkers and Imaging Studies 141
Karin Potthoff, Ulrike Fiedler, and Joachim Drevs
6 Cardiovascular Biomarkers as Examples of Success and Failure in Predicting Safety in Humans 163
Simon Authier, Michael K. Pugsley, Eric Troncy, and Michael J. Curtis
7 The Use of Molecular Imaging for Receptor Occupancy Decision Making in Drug Development 189
Ralph Paul Maguire
8 Biosensors for Clinical Biomarkers 203
Sara Tombelli and Marco Mascini
Part III Regulatory Perspectives 229
9 Regulatory Perspectives on Biomarker Development 231
Rajanikanth Madabushi, Lawrence Lesko, and Janet Woodcock
10 Perspectives from the European Regulatory Authorities 255
Ian Hudson
11 Use of Biomarker in Drug Development—Japanese Perspectives 269
Yoshiaki Uyama, Akihiro Ishiguro, Harumasa Nakamura, and Satoshi Toyoshima
Part IV Predicting in Vivo 289
12 In Vitro–In Vivo Correlations of Hepatic Drug Clearance 291
R. Scott Obach
13 The Potential of In Silico and In Vitro Approaches to Predict In Vivo Drug–Drug Interactions and ADMET/TOX Properties 307
Kenneth Bachmann and Sean Ekins
14 In Vitro–In Vivo Correlations in Drug Discovery and Development: Concepts and Applications inToxicology 331
Rex Denton, Kimberly Brannen, and Bruce D. Car
15 Assessing the Potential for Induction of Cytochrome P450 Enzymes and Predicting the In Vivo Response 353
Jiunn H. Lin
Index 383
