Predictive Approaches in Drug Discovery and Development: Biomarkers and in Vitro / In Vivo Correlations

ISBN-13: 9780470170830 / Angielski / Twarda / 2012 / 408 str.

J. Andrew Williams; Richard LaLonde; Jeffrey R. Koup

Opis

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.

Recenzje

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)

Spis treści

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

O autorze

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.

Blurb

Comprehensive coverage of biomarker research applied to drug discovery and development

Two key factors have emerged in the race to discover approvable new drugs faster and with fewer resources: biomarkers and in vitro/in vivo correlations (IVIVC). Predictive Approaches in Drug Discovery and Development: Biomarkers and In Vitro/In Vivo Correlations provides comprehensive coverage of how these factors are enhancing the drug pipeline and accelerating development.

An invaluable resource, the book presents essential information on the importance of biomarkers in translational medicine, the clinical applications of biomarkers, relevant regulatory perspectives, and the potential of in vivo research. With each chapter written by one or more expert authors from the global front lines of the pharmaceutical industry and regulatory agencies, the book also incorporates academic research that unites these two fields and describes their applications, from technical lab experiments to strategic management.

Covering many aspects of biomarker research as applied to drug discovery and development, the book brings together state–of–the–art appraisals of the practical utility of "–omics", biochemical, and protein biomarkers with case histories and lessons from successful and unsuccessful real–world applications. Regulatory agency perspectives and initiatives in the United States and around the world are also discussed, as are GLP validation and, safety biomarkers, and proteomic biomarkers.

Biomarkers and IVIVC present unique opportunities for identifying more robust clinical candidates and selecting leads more intelligently, making Predictive Approaches in Drug Discovery and Development a must–have for researchers and professionals in the pharmaceutical and biotechnology industries, as well as for use in advanced graduate and undergraduate courses.