The Path from Biomarker Discovery to Regulatory Qualification

The Path from Biomarker Discovery to Regulatory Qualification

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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:
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Product details

  • Paperback | 206 pages
  • 190.5 x 233.68 x 12.7mm | 430.91g
  • Academic Press Inc
  • San Diego, United States
  • English
  • Illustrated; Illustrations, unspecified
  • 0123914965
  • 9780123914965

Table of contents


1. Biomarker Applications in the Pharmaceutical Industry 2. The Impact of Biomarker Qualification Regulatory Processes on the Critical Path for Drug Development 3. Regulatory Experience at the EMA 4. Regulatory Experience at the PMDA

Section 1: Biomarker Development and Qualification in the Pharmaceutical Industry

5. Pfizer 6. Astra Zeneca 7. Novartis 8. BMS 9. CTCs

Section 2: Toxicogenomic Biomarkers

10. Gene Logic 11. Johnson and Johnson 12. ILSI-HESI

Section 3: Biomarkers of Drug Safety

13. "Classic" Markers of Liver Injury 14. Urinary Biomarkers of Kidney Injury

Section 4: Consortia

15. ILSI-HESI 16. C-Path Institute 17. Beyond QT

Section 5: Path to Regulatory Qualification Process Development

18. FDA 19. PMDA 20. The tortuous path from development to qualification of biomarkers
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Review quote

"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.", 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
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About 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
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