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The Path from Biomarker Discovery to Regulatory Qualification

The Path from Biomarker Discovery to Regulatory Qualification
A Book

by Federico Goodsaid,William B. Mattes

  • Publisher : Academic Press
  • Release : 2013-07-16
  • Pages : 206
  • ISBN : 0123944082
  • Language : En, Es, Fr & De
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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: 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.

Handbook of Biomarkers and Precision Medicine

Handbook of Biomarkers and Precision Medicine
A Book

by Claudio Carini,Mark Fidock,Alain van Gool

  • Publisher : CRC Press
  • Release : 2019-04-16
  • Pages : 631
  • ISBN : 0429576730
  • Language : En, Es, Fr & De
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"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 and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development. Features: Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies Lessons-learned from successful Precision Medicine case studies A variety of exciting and emerging biomarker technologies The next frontiers and future challenges of biomarkers in Precision Medicine Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings’s College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.

Oncology

Oncology
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2006
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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American Journal of Respiratory and Critical Care Medicine

American Journal of Respiratory and Critical Care Medicine
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2007
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Nature

Nature
A Book

by Sir Norman Lockyer

  • Publisher : Unknown Publisher
  • Release : 2008
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Pharmacogenomics and Proteomics

Pharmacogenomics and Proteomics
Enabling the Practice of Personalized Medicine

by Steven How-Yan Wong,Mark W. Linder,Roland Valdes

  • Publisher : AACC Press
  • Release : 2006
  • Pages : 386
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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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, and metabonomics; specific clinical applications of pharmacogenetics of major drug groups, specialties, and diseases, and how they are linked to potential clinical management; and selected biotechnologies relevant to the application of clinical pharmacogenomics and proteomics to clinical practice.

The Journal of Nuclear Medicine

The Journal of Nuclear Medicine
JNM

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2008
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Genetic Engineering News

Genetic Engineering News
GEN.

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2005
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Who's who in Science and Engineering

Who's who in Science and Engineering
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2008
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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