Full Product Details
Author: Federico Goodsaid (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)
Publisher: Elsevier Science Publishing Co Inc
Imprint: Academic Press Inc
Dimensions:
Width: 15.20cm
, Height: 1.00cm
, Length: 22.90cm
Weight: 0.450kg
ISBN: 9780123914965
ISBN 10: 0123914965
Pages: 206
Publication Date: 12 September 2013
Audience:
Professional and scholarly
,
Professional & Vocational
Format: Paperback
Publisher's Status: Active
Availability: Manufactured on demand
We will order this item for you from a manufactured on demand supplier.
Reviews
This book focuses on the use of biomarkers in drug development, for efficacy and targeted drug therapy as well as for predicting drug harm. It is a collection of papers that present the authors' examples of their work using biomarkers, not only for drug development but also for regulatory review. --Doody.com, January 3, 2014*** Scientists from academia, drug companies, and regulatory agencies explore ways to develop biomarkers and integrate them in both developing and regulating drugs. They cover the impact of biomarker qualification regulatory processes on the critical path for drug development, biomarker development and qualification in the pharmaceutical industry, toxicogenomic biomarkers, biomarkers of drug safety, consortia, and the path to regulatory qualification process development. --Reference & Research Book News, December 2013
""This book focuses on the use of biomarkers in drug development, for efficacy and targeted drug therapy as well as for predicting drug harm. It is a collection of papers that present the authors' examples of their work using biomarkers, not only for drug development but also for regulatory review."" --Doody.com, January 3, 2014 ""Scientists from academia, drug companies, and regulatory agencies explore ways to develop biomarkers and integrate them in both developing and regulating drugs. They cover the impact of biomarker qualification regulatory processes on the critical path for drug development, biomarker development and qualification in the pharmaceutical industry, toxicogenomic biomarkers, biomarkers of drug safety, consortia, and the path to regulatory qualification process development."" --Reference and Research Book News, December 2013
Author Information
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
