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The Path from Biomarker Discovery to Regulatory Qualification
A valuable collection of experiences and perspectives on biomarker qualification, its history and current practice in regulatory settings for those working in the biomarker development, pharmaceutical and regulatory communities
Federico Goodsaid (Edited by), William B. Mattes (Edited by)
9780123914965, Elsevier Science
Paperback, published 12 September 2013
206 pages
22.9 x 15.1 x 1.4 cm, 0.45 kg
"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
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
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
Subject Areas: Biochemistry [PSB], Medical toxicology [MMGT], Pharmacology [MMG], Physiology [MFG], Medical laboratory testing & techniques [MBGL]
