Predictive Approaches in Drug Discovery and Development (eBook)

Biomarkers and In Vitro / In Vivo Correlations

J. Andrew Williams, Richard Lalonde, Jeffrey R. Koup, David D. Christ (Herausgeber)

eBook Download: PDF

2012
John Wiley & Sons (Verlag)
978-1-118-23025-1 (ISBN)

Infos

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.

Autor

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.

Inhalt

PREDICTIVEAPPROACHES IN DRUGDISCOVERYAND DEVELOPMENT 3
CONTENTS 9
PREFACE 13
ACKNOWLEDGMENTS 15
CONTRIBUTORS 17
PART I BIOMARKERS IN DRUG DISCOVERY 21
1 The Importance of Biomarkersin Translational Medicine 23
2 Validation of Biochemical Biomarker Assays used in DrugDiscovery and Development: A Review of Challengesand Solutions 43
3 Proteomic Methods to Develop Protein Biomarkers 69
4 Overview of Metabolomics Basics 99
PART II CLINICAL APPLICATION OF BIOMARKERS 159
5 Vascular Biomarkers and Imaging Studies 161
6 Cardiovascular Biomarkers as Examples of Success andFailure in Predicting Safety in Humans 183
7 The Use of Molecular Imaging for Receptor OccupancyDecision Making in Drug Development 209
8 Biosensors for Clinical Biomarkers 223
PART III REGULATORY PERSPECTIVES 249
9 Regulatory Perspectives on Biomarker Development 251
10 Perspectives from the European Regulatory Authorities 275
11 Use of Biomarker in Drug Development—JapanesePerspectives 289
PART IV PREDICTING IN VIVO 309
12 In Vitro–In Vivo Correlations of Hepatic Drug Clearance 311
13 The Potential of In Silico and In Vitro Approaches to PredictIn Vivo Drug–Drug Interactions and ADMET/TOX Properties 327
14 In Vitro–In Vivo Correlations in Drug Discovery andDevelopment: Concepts and Applications in Toxicology 351
15 Assessing the Potential for Induction of Cytochrome P450Enzymes and Predicting the In Vivo Response 373
INDEX 403

Rezensionen

"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)

Produkt-Details

• Erscheint lt. Verlag: 15.2.2012
• Reihe/Serie: Wiley Series on Technologies for the Pharmaceutical
• Reihe/Serie: Wiley Series on Technologies for the Pharmaceutical
• Reihe/Serie: Wiley Series on Technologies for the Pharmaceutical Industry
• Mitarbeit: Herausgeber (Serie): Sean Ekins
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
• Themenwelt: Medizin / Pharmazie ► Pharmazie
• Themenwelt: Naturwissenschaften ► Chemie
• Themenwelt: Technik
• Themenwelt: Wirtschaft
• Schlagworte: Analytical Chemistry • Analytische Chemie • biomarkers, in vivo in vitro correlations, IVIVC, biotech research, biotech, pharmaceutical industry, pharmaceutical research, drug development • Chemie • Chemistry • Drug Discovery & Development • Medical Science • Medizin • Pharmacology & Pharmaceutical Medicine • Pharmakologie u. Pharmazeutische Medizin • Toxikologie • Wirkstoffforschung • Wirkstoffforschung u. -entwicklung
• ISBN-10: 1-118-23025-6 / 1118230256
• ISBN-13: 978-1-118-23025-1 / 9781118230251