Predictive approaches in drug discovery and development : biomarkers and in vitro/in vivo correlations
Author(s)
Bibliographic Information
Predictive approaches in drug discovery and development : biomarkers and in vitro/in vivo correlations
（Wiley series on technologies for the pharmaceutical industry）
Wiley, c2012
- : hbk.
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Note
Includes bibliographical references and index
Description and Table of Contents
Description
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.
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
by "Nielsen BookData"
