Biomarkers in Drug Development - A Handbook of Practice, Application, and Strategy

Klappentext By focusing on how to identify! develop! and integrate biomarkers into drug development! this book will improve biomarker use and enhance pharmaceutical decision making. The coverage includes case studies showing how biomarkers can substantively impact drug development timelines and costs! enable better compound selection and reduce late stage attrition! and facilitate personalized medicine. It describes biomarker technologies! characterization and validation! and applications including in discovery! preclinical safety assessment! clinical trials! and translational medicine. The text! a useful resource for the pharmaceutical industry! also looks at practical issues and intellectual property concerns. Zusammenfassung By focusing on how to identify, develop, and integrate biomarkers into drug development, this book will improve biomarker use and enhance pharmaceutical decision making. The coverage includes case studies showing how biomarkers can substantively impact drug development timelines and costs, enable better compound selection and reduce late stage attrition, and facilitate personalized medicine. It describes biomarker technologies, characterization and validation, and applications including in discovery, preclinical safety assessment, clinical trials, and translational medicine. The text, a useful resource for the pharmaceutical industry, also looks at practical issues and intellectual property concerns. Inhaltsverzeichnis Part 1 - What is a Biomarker and Role in Drug Development.1. Biomarkers are Not New (Ian Dews).2. Biomarkers: Facing the Challenges at the Crossroads of Research and Health Care (Gregory J. Downing).3. Enabling Go/No-Go Decisions (J. Fred Pritchard and Mallé Jurima-Romet).Part 2 - Identifying New Biomarkers: Technology Approaches .4. Imaging as a Localized Biomarker: Opportunities and Challenges (Jonathan Moody, Philip S. Murphy, Edward P. Ficaro).5. Protein Biomarker Discovery Using Mass Spectrometry Based Proteomics (Joanna M. Hunter and Daniel Chelsky).6. Quantitative Multiplexed Patterning of Immune-Related Biomarkers (Dominic Eisinger, Ralph McDade, and Thomas Joos).7. Gene Expression Profiles as Preclinical and Clinical Cancer Biomarkers of Prognosis, Drug Response, and Drug Toxicity (Jason A. Sprowl and Amadeo M. Parissenti).8. The Use of High Through-Put Proteomic Arrays for the Discovery of Disease-Associated Molecules (Douglas M. Molina, W. John W. Morrow, and Xiaowu Liang).Part 3 - Characterization and Validation.9. Characterization and Validation Biomarkers in Drug Development: A Regulatory Perspective (Federico Goodsaid).10. "Fit for Purpose" Method Validation and Assays for Biomarker Characterization to Support Drug Development (Jean W. Lee, Yuling Wu, and Jin Wang).11. Molecular Biomarkers from a Diagnostic Perspective (Klaus Lindpaintner).12. Strategies for the Co-Development of Drugs and Diagnostics - An FDA Perspective on Diagnostics Regulation (Francis Kalush and Steven Gutman).13. Importance of Statistics in the Qualification and Application of Biomarkers (Mary Zacour).Part 4 - Biomarkers in Discovery and Pre-Clinical Safety.14. Qualification of Safety Biomarkers for Application to Early Drug Development (William B. Mattes and Frank D. Sistare).15. Development of Serum Calcium and Phosphorus as Clinical Biomarkers for Drug-Induced Systemic Mineralization: Case Study with a MEK Inhibitor (Alan P. Brown).16. Biomarkers for the Immunogenicity of Therapeutic Proteins and its Clinical Consequences (Claire Cornips and Huub Shellekens).17. New Markers of Kidney Injury (Sven Beushausen).Part 5 - Translating From Pre-Clinical Results to Clinical and Back.18. Translational Medicine - A Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers (Giora Z. Feuerstein, Salvatore Alesci, Frank L. Walsh, J. Lynn Rutkowski, Robert R. Ruffolo, Jr.).19. Clinical Validation and Biomar...

Product details

• Authors: Michael R. Bleavins, Michael R. Carini Bleavins, Claudio Carini, Mallé Jurima-Romet, Ramin Rahbari
• Publisher: Wiley, John and Sons Ltd
• Languages: English
• Product format: Hardback
• Released: 26.01.2010
• EAN: 9780470169278
• ISBN: 978-0-470-16927-8
• No. of pages: 784
• Subject: Natural sciences, medicine, IT, technology > Chemistry