The Path from Biomarker Discovery to Regulatory Qualification - Softcover

 
9780123914965: The Path from Biomarker Discovery to Regulatory Qualification
Softcover
ISBN 10: 0123914965 ISBN 13: 9780123914965
Publisher: Academic Press, 2013

Synopsis

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

  • Contains a collection of experiences of different groups taking different types of biomarkers to different levels of qualification and provides insightful case studies of an important area of regulatory science
  • Focuses on practical advice, concepts, strategies and overall outcomes to support those working toward biomarker qualification for clinical use
  • Offers a valuable resource for members of the regulatory, pharmaceutical and biomarker development communities

"synopsis" may belong to another edition of this title.

About the Authors

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

"About this title" may belong to another edition of this title.

Publisher
Academic Press
Publication date
2013
Language
English
ISBN 10 
0123914965
ISBN 13 
9780123914965
Binding
Paperback
Edition number
1
Number of pages
206
Editor
Goodsaid Federico, Mattes William B.