The Path from Biomarker Discovery to Regulatory Qualification

Federico Goodsaid, William B. Mattes (Herausgeber)

Buch | Softcover

206 Seiten

2013
Academic Press Inc (Verlag)
978-0-12-391496-5 (ISBN)

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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.

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

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

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

Erscheint lt. Verlag	12.9.2013
Verlagsort	San Diego
Sprache	englisch
Maße	152 x 229 mm
Gewicht	450 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Laboratoriumsmedizin
	Studium ► 1. Studienabschnitt (Vorklinik) ► Physiologie
	Naturwissenschaften ► Biologie ► Biochemie
ISBN-10	0-12-391496-5 / 0123914965
ISBN-13	978-0-12-391496-5 / 9780123914965
Zustand	Neuware