The Path from Biomarker Discovery to Regulatory Qualification - Brossura

 
9780123914965: The Path from Biomarker Discovery to Regulatory Qualification
Brossura
ISBN 10: 0123914965 ISBN 13: 9780123914965
Casa editrice: Academic Press, 2013

Sinossi

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

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Informazioni sugli autori

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

Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.

Editore
Academic Press
Data di pubblicazione
2013
Lingua
Inglese
ISBN 10 
0123914965
ISBN 13 
9780123914965
Rilegatura
Copertina flessibile
Numero edizione
1
Numero di pagine
206
Redattore
Goodsaid Federico
Contatto del produttore
non disponibile
Persona responsabile
non disponibile