Predictive Approaches in Drug Discovery and Development: Biomarkers and In Vitro / In Vivo Correlations (Wiley Series on Technologies for the Pharmaceutical Industry) - Hardcover

Hardcover

ISBN 10: 0470170832 ISBN 13: 9780470170830

Publisher: Wiley, 2012

Synopsis

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.

About this title

About the Author

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.

From the Back Cover

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.

From the Inside Flap

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.

Edition details

• Publisher: Wiley
• Publication date: 2012
• Language: English
• ISBN 10: 0470170832
• ISBN 13: 9780470170830
• Binding: Hardcover
• Edition number: 1
• Number of pages: 416
• Editor: Williams J. Andrew, Lalonde Richard, Koup Jeffrey R., Christ David D.