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The path from biomarker discovery to regulatory qualification

Record Type:	Language materials, printed : Monograph/item
Title/Author:	The path from biomarker discovery to regulatory qualification/ Federico Goodsaid, Strategic Regulating Intelligence, Regulatory Affairs, Vertex Pharmaceuticals, Washingon DC, USA, William B. Mattes, PharmPoint Consulting, Poolesville, Maryland, USA.
Author:	Goodsaid, Federico.
other author:	Mattes, William B.
Published:	Amsterdam :Elsevier/Academic Press, : 2013.,
Description:	xiii, 192 p. :ill. ; : 24 cm.;
Subject:	Biochemical markers. -
Online resource:	http://www.sciencedirect.com/science/book/9780123914965
ISBN:	9780123914965 (electronic bk.)

The path from biomarker discovery to regulatory qualification
Goodsaid, Federico.

The path from biomarker discovery to regulatory qualification[electronic resource] /Federico Goodsaid, Strategic Regulating Intelligence, Regulatory Affairs, Vertex Pharmaceuticals, Washingon DC, USA, William B. Mattes, PharmPoint Consulting, Poolesville, Maryland, USA. - Amsterdam :Elsevier/Academic Press,2013. - xiii, 192 p. :ill. ;24 cm.

Includes bibliographical references and index.

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. 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.

ISBN: 9780123914965 (electronic bk.)

LCCN: 2012276154Subjects--Topical Terms:

582469
Biochemical markers.

LC Class. No.: R853.B54 / G66 2013

Dewey Class. No.: 610.28

The path from biomarker discovery to regulatory qualification
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504 $a Includes bibliographical references and index.
520 $a 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. 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.
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700 1 $a Mattes, William B. $3 1004547
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