The Path from Biomarker Discovery to Regulatory Qualification
Author(s): Federico Goodsaid (Editor), William B. Mattes (Series Editor)
Publisher: Academic Press
Publication Date: 7 Aug. 2013
Edition: Illustrated
Language: English
Print length: 206 pages
ISBN-10: 0123914965
ISBN-13: 9780123914965
Book Description
The Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book-it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science. For complimentary access to chapter 13, ‘Classic’ Biomarkers of Liver Injury, by John R. Senior, Associate Director for Science, Food and Drug Administration, Silver Spring, Maryland, USA, please visit the following site: http://tinyurl.com/ClassicBiomarkers
Editorial Reviews
Review
“This book focuses on the use of biomarkers in drug development, for efficacy and targeted drug therapy as well as for predicting drug harm. It is a collection of papers that present the authors’ examples of their work using biomarkers, not only for drug development but also for regulatory review.” —Doody.com, January 3, 2014
“Scientists from academia, drug companies, and regulatory agencies explore ways to develop biomarkers and integrate them in both developing and regulating drugs. They cover the impact of biomarker qualification regulatory processes on the critical path for drug development, biomarker development and qualification in the pharmaceutical industry, toxicogenomic biomarkers, biomarkers of drug safety, consortia, and the path to regulatory qualification process development.” —Reference and Research Book News, December 2013
Review
A valuable collection of experiences and perspectives on biomarker qualification, its history and current practice in regulatory settings for those working in the biomarker development, pharmaceutical and regulatory communities
About the Author
PhD, Vice President, Strategic Regulatory Intelligence, Vertex Pharmaceuticals, Cambridge, MA
William B. Mattes, PhD, DABT, Senior Director of COPD Biomarkers Qualification Consortium, COPD Foundation and Founder and Principal, PharmPoint Consulting
Wow! eBook
