The Path from Biomarker Discovery to Regulatory Qualification

Written By Federico Goodsaid
The Path from Biomarker Discovery to Regulatory Qualification
  • Publsiher : Academic Press
  • Release : 16 July 2013
  • ISBN : 0123944082
  • Pages : 206 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled The Path from Biomarker Discovery to Regulatory Qualification written by Federico Goodsaid which was release on 16 July 2013, this book published by Academic Press. Available in PDF, EPUB and Kindle Format. Book excerpt: 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.

The Path from Biomarker Discovery to Regulatory Qualification

The Path from Biomarker Discovery to Regulatory Qualification
  • Author : Federico Goodsaid,William B. Mattes
  • Publisher : Academic Press
  • Release Date : 2013-07-16
  • Total pages : 206
  • ISBN : 0123944082
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Summary : 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, ...

Handbook of Biomarkers and Precision Medicine

Handbook of Biomarkers and Precision Medicine
  • Author : Claudio Carini,Mark Fidock,Alain van Gool
  • Publisher : CRC Press
  • Release Date : 2019-04-16
  • Total pages : 631
  • ISBN : 0123944082
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Summary : "The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge ...

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  • Publisher : John Wiley & Sons
  • Release Date : 2016-03-16
  • Total pages : 584
  • ISBN : 0123944082
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Summary : As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. • Guides researchers as to what drug safety experiments are both practical and useful • Covers ...

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  • Publisher : Unknown
  • Release Date : 2006
  • Total pages : 212
  • ISBN : 0123944082
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American Journal of Respiratory and Critical Care Medicine
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  • Publisher : Unknown
  • Release Date : 2007
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  • ISBN : 0123944082
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  • Author : Sir Norman Lockyer
  • Publisher : Unknown
  • Release Date : 2008
  • Total pages : 212
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Pharmacogenomics and Proteomics
  • Author : Steven How-Yan Wong,Mark W. Linder,Roland Valdes
  • Publisher : AACC Press
  • Release Date : 2006
  • Total pages : 386
  • ISBN : 0123944082
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Summary : Reviews the fundamentals of molecular biology and general clinical implications important in understanding fundamental concepts, a general review of ethical considerations, methods of predicting response using artificial networks, regulatory issues, reimbursement, quality assurance considerations, and future market analysis; methodologies that merge the disciplines of pharmacogenetics with those of proteomics, metabolomics, ...

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  • Publisher : Unknown
  • Release Date : 2008
  • Total pages : 212
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Genetic Engineering News
  • Author : Anonim
  • Publisher : Unknown
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  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2008
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