The Path from Biomarker Discovery to Regulatory Qualification

Informationen zum Autor 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 Klappentext With the evolution of translational and personalized medicine, there is growing excitement surrounding the use of biomarkers as an important tool to increase efficiency in drug discovery. The reality, however, is that without biomarker qualification or regulatory approval, scientists are unable to use the biomarker to support drug registration. The Path from Biomarker Discovery to Regulatory Qualification is a collection of experiences, challenges and outcomes from different groups worldwide who have been involved in biomarker qualification. Each chapter will focus on overall concepts, strategies and outcomes, providing those individuals in the regulatory, pharmaceutical and biomarker development communities with an insightful and practical guide to biomarker qualification. Zusammenfassung Focuses on biomarker qualification, its history and regulatory settings in both the US and abroad. This book provides a 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.

Product details

• Authors: Federico Goodsaid, Federico (EDT)/ Mattes Goodsaid
• Assisted by: Federico Goodsaid (Editor), Federico (PhD Goodsaid (Editor), Goodsaid Federico (Editor), W.B. (PhD Mattes (Editor), William B. Mattes (Editor), William B. (PhD Mattes (Editor), Mattes William B. (Editor)
• Publisher: Academic Press London
• Languages: English
• Product format: Paperback / Softback
• Release: 01.08.2013, delayed
• EAN: 9780123914965
• ISBN: 978-0-12-391496-5
• No. of pages: 208
• Series: Academic Press
• Subjects: Natural sciences, medicine, IT, technology > Medicine > Non-clinical medicine; PHYSIOLOGY, SCIENCE / Life Sciences / Biochemistry, MEDICAL / Physiology, MEDICAL / Laboratory Medicine, biochemistry, Medical laboratory testing & techniques, Medical laboratory testing and techniques