大葉大學圖書館 |

The path from biomarker discovery to regulatory qualification[electronic resource] /

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
杜威分類號:	610.28
書名/作者:	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.
作者:	Goodsaid, Federico.
其他作者:	Mattes, William B.
出版者:	Amsterdam : : Elsevier/Academic Press,, 2013.
面頁冊數:	xiii, 192 p. : : ill. ;; 24 cm.
標題:	Biochemical markers.
ISBN:	9780123914965 (electronic bk.)
ISBN:	9780123914965
書目註:	Includes bibliographical references and index.
摘要、提要註:	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.
電子資源:	http://www.sciencedirect.com/science/book/9780123914965

The path from biomarker discovery to regulatory qualification[electronic resource] /
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:

431086
Biochemical markers.

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

Dewey Class. No.: 610.28

The path from biomarker discovery to regulatory qualification[electronic resource] /
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