The Path from Biomarker Discovery to Regulatory Qualification
ISBN 10: 0123914965 ISBN 13: 9780123914965
Published by Elsevier, 2013
New
Soft cover
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Books Puddle, Woodside, NY, U.S.A.
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About this Item
Description:
pp. 208. Seller Inventory # 2651427933
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
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
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Bibliographic Details
Title: The Path from Biomarker Discovery to ...
Publisher: Elsevier
Publication Date: 2013
Binding: Soft cover
Condition: New