The Path from Biomarker Discovery to Regulatory Qualification
  • Release Date : 16 July 2013
  • Publisher : Academic Press
  • Categories : Medical
  • Pages : 206 pages
  • ISBN 13 : 9780123944085
  • ISBN 10 : 0123944082
Score: 4
From 245 Ratings
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Synopsis : The Path from Biomarker Discovery to Regulatory Qualification written by Federico Goodsaid, published by Academic Press which was released on 16 July 2013. Download The Path from Biomarker Discovery to Regulatory Qualification Books now! Available in PDF, EPUB, Mobi Format. 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 Contains a collection of experiences of different groups taking different types of biomarkers to different levels of qualification and provides insightful case studies of an important area of regulatory science Focuses on practical advice, concepts, strategies and overall outcomes to support those working toward biomarker qualification for clinical use Offers a valuable resource for members of the regulatory, pharmaceutical and biomarker development communities.

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Publisher : National Academies Press
Category : Medical
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