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Full Product Details

Author:   J. Andrew Williams ,  Richard Lalonde ,  Jeffrey R. Koup ,  David D. Christ
Publisher:   John Wiley & Sons Inc
Imprint:   John Wiley & Sons Inc
Dimensions:   Width: 16.40cm , Height: 2.80cm , Length: 24.10cm
Weight:   0.721kg
ISBN:  

9780470170830

ISBN 10:   0470170832
Pages:   416
Publication Date:   19 April 2012
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   Out of stock  
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Table of Contents

PREFACE 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 of Challenges 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 in Toxicology 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

Reviews

<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. (Doody s, 8 February 2013) <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. (ISSX International Society for the Study of Xenobiotics, 1 December 2012)

<p> The ability to correlate in vitro and in vivo biomarkerinformation in the process of drug discovery and development liesat the heart of translational research. The goal is to rapidlytranslate basic discoveries into clinical applications. This bookprovides state-of-the-art information on this exciting new researchapproach. (Doody s, 8 February 2013) <p> The text is packed with interesting, comprehensive, andpertinent information, clearly presented with salient pointsreinforced by inclusion in text boxes ... This is an admirabletextbook for those dealing with drug discovery and development. Ienjoyed reading through it and I would recommend it to anyone whohas an interest, or is developing an interest, in the field ofbiomarkers and their, as yet, unfulfilled potential. (ISSX International Society for the Study of Xenobiotics, 1December 2012)

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)

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)

Author Information

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

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