The Path from Biomarker Discovery to Regulatory Qualification (BOK)

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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.

Produktfakta

Språk Engelsk Engelsk Innbinding Heftet
Utgitt 2013 Forlag
ACADEMIC PRESS
ISBN 9780123914965 Antall sider 206
Dimensjoner 15,2cm x 22,9cm x 1cm Vekt 408 gram
Leverandør Bertram Trading Ltd Andre medvirkende Federico Goodsaid, William B. Mattes
Emner og form Physiology, Biochemistry, Medical laboratory testing & techniques