Tools

LEADER 03513nam 22004817i 4500

001 ssj0001085764;

003 WaSeSS;

005 20240712080447.0;

006 m d ;

007 cr n ;

008 140402t20132013enka sb 001 0 eng d;

010 a| 2012276154;

016 7 a| 0164482292| Uk;

020 a| 9780123914965 (pbk.);

020 a| 0123914965 (pbk.);

020 z| 9780123944085 (ebook);

035 a| (WaSeSS)ssj0001085764;

042 a| lccopycat;

049 a| EREEa| NEHH;

050 00 a| R853.B54b| G66 2013;

082 00 a| 610.282| 23;

100 1 a| Goodsaid, Federico.?| UNAUTHORIZED;

245 14 a| The path from biomarker discovery to regulatory qualificationh| [electronic resource] /c| Federico Goodsaid, Strategic Regulating Intelligence, Regulatory Affairs, Vertex Pharmaceuticals, Washington DC, USA, William B. Mattes, PharmPoint Consulting, Poolesville, Maryland, USA.;

300 a| xiii, 192 pages :b| illustrations ;c| 24 cm;

504 a| Includes bibliographical references and index.;

506 a| Available only to authorized users.;

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.;

538 a| Mode of access: World Wide Web;

650 0 a| Biochemical markers.=| ^A160152;

655 0 a| Electronic books.=| ^A491897;

700 1 a| Mattes, William B.?| UNAUTHORIZED;

856 40 z| Full text available from eBook - Pharmacology, Toxicology and Pharmaceutical Science 2013 [EBCPTPS13]u| https://go.openathens.net/redirector/ecu.edu?url=https%3A%2F%2Fwww.sciencedirect.com%2Fscience%2Fbook%2F9780123914965;

947 a| (OCoLC)ocn832288614;

949 a| CLICK ON WEB ADDRESSw| ASISh| JOYNER188;

949 a| CLICK ON WEB ADDRESSw| ASISh| HSL77;

949 a| CLICK ON WEB ADDRESSw| ASISh| JMUSIC60;

596 a| 1 3 4;

998 a| 6459515;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 6459515-1001l| JNETm| JOYNERr| Ys| Yt| JNESSBKu| 7/21/2024x| EBOOKz| JERESOURCE;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 6459515-2001l| HSLELECm| HSLr| Ys| Yt| HEBKu| 7/21/2024x| EBOOKz| HERESOURCE;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 6459515-3001l| MNETm| JMUSICr| Ys| Yt| MNESSBKu| 7/21/2024x| EBOOKz| JERESOURCE;

The path from biomarker discovery to regulatory qualification / Federico Goodsaid, Strategic Regulating Intelligence, Regulatory Affairs, Vertex Pharmaceuticals, Washington DC, USA, William B. Mattes, PharmPoint Consulting, Poolesville, Maryland, USA.

Author/creator	Goodsaid, Federico
Other author	Mattes, William B.
Format	Electronic
Publication Info	Amsterdam ; Boston ; Heidelberg ; London ; New York ; Oxford ; Paris ; San Diego ; San Francisco ; Singapore ; Sydney ; Tokyo : Elsevier / AP, [2013]
Description	xiii, 192 pages : illustrations ; 24 cm
Supplemental Content	Full text available from eBook - Pharmacology, Toxicology and Pharmaceutical Science 2013 [EBCPTPS13]
Subjects	Biochemical markers.

Abstract	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.
Bibliography note	Includes bibliographical references and index.
Access restriction	Available only to authorized users.
Technical details	Mode of access: World Wide Web
Genre/form	Electronic books.
LCCN	2012276154
ISBN	9780123914965 (pbk.)
ISBN	0123914965 (pbk.)

Availability

Library	Location	Call Number	Status	Item Actions
	Electronic Resources	Access Content Online	✔ Available

The path from biomarker discovery to regulatory qualification / Federico Goodsaid, Strategic Regulating Intelligence, Regulatory Affairs, Vertex Pharmaceuticals, Washington DC, USA, William B. Mattes, PharmPoint Consulting, Poolesville, Maryland, USA.

Click here for more information about this title

Availability