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 ...

Translational Medicine Tools And Techniques

Translational Medicine  Tools And Techniques
  • Author : Aamir Shahzad
  • Publisher : Academic Press
  • Release Date : 2015-11-24
  • Total pages : 196
  • ISBN : 0123944082
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Summary : Translational Medicine: Tools and Techniques provides a standardized path from basic research to the clinic and brings together various policy and practice issues to simplify the broad interdisciplinary field. With discussions from academic and industry leaders at international institutions who have successfully implemented translational medicine techniques and tools in various ...

Biomarkers of Kidney Disease

Biomarkers of Kidney Disease
  • Author : Charles L. Edelstein
  • Publisher : Academic Press
  • Release Date : 2016-11-08
  • Total pages : 632
  • ISBN : 0123944082
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Summary : Biomarkers of Kidney Disease, Second Edition, focuses on the basic and clinical research of biomarkers in common kidney diseases, detailing the characteristics of an ideal biomarker. The latest techniques for biomarker detection, including metabolomics and proteomics are covered in the book. This comprehensive book details the latest advances made in ...

Ensuring National Biosecurity

Ensuring National Biosecurity
  • Author : Carole R Baskin,Alan Zelicoff
  • Publisher : Academic Press
  • Release Date : 2016-02-03
  • Total pages : 270
  • ISBN : 0123944082
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Summary : Ensuring National Biosecurity: Institutional Biosafety Committees reviews the various responsibilities and associated challenges Institutional Biosafety Committees (IBCs) face and proposes changes that may help improve this system and increase national biosecurity and worker safety. In recent years IBCs in academic and other institutions have been tasked with increasing levels of ...

Current Topics in Nonclinical Drug Development

Current Topics in Nonclinical Drug Development
  • Author : Pritam S. Sahota,Philip Bentley,Zbigniew Wojcinski
  • Publisher : CRC Press
  • Release Date : 2020-12-23
  • Total pages : 318
  • ISBN : 0123944082
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Summary : The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent ...

Biomarkers in Drug Discovery and Development

Biomarkers in Drug Discovery and Development
  • Author : Ramin Rahbari,Jonathan Van Niewaal,Michael R. Bleavins
  • Publisher : John Wiley & Sons
  • Release Date : 2020-02-28
  • Total pages : 608
  • ISBN : 0123944082
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Summary : This book continues the legacy of a well-established reference within the pharmaceutical industry – providing perspective, covering recent developments in technologies that have enabled the expanded use of biomarkers, and discussing biomarker characterization and validation and applications throughout drug discovery and development. • Explains where proper use of biomarkers can substantively impact ...

Drug Discovery and Evaluation Methods in Clinical Pharmacology

Drug Discovery and Evaluation  Methods in Clinical Pharmacology
  • Author : H.Gerhard Vogel,Jochen Maas,Alexander Gebauer
  • Publisher : Springer Science & Business Media
  • Release Date : 2010-12-15
  • Total pages : 564
  • ISBN : 0123944082
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Summary : Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these ...

Biomarkers in Drug Development

Biomarkers in Drug Development
  • Author : Michael R. Bleavins,Claudio Carini,Mallé Jurima-Romet,Ramin Rahbari
  • Publisher : John Wiley & Sons
  • Release Date : 2011-09-20
  • Total pages : 784
  • ISBN : 0123944082
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Summary : Discover how biomarkers can boost the success rate of drugdevelopment efforts As pharmaceutical companies struggle to improve the success rateand cost-effectiveness of the drug development process, biomarkershave emerged as a valuable tool. This book synthesizes and reviewsthe latest efforts to identify, develop, and integrate biomarkersas a key strategy in translational ...

Drug Discovery and Development

Drug Discovery and Development
  • Author : Izet Kapetanović
  • Publisher : BoD – Books on Demand
  • Release Date : 2011-12-16
  • Total pages : 542
  • ISBN : 0123944082
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Summary : Drug discovery and development process aims to make available medications that are safe and effective in improving the length and quality of life and relieving pain and suffering. However, the process is very complex, time consuming, resource intensive, requiring multi-disciplinary expertise and innovative approaches. There is a growing urgency to ...

Advancing the Discipline of Regulatory Science for Medical Product Development

Advancing the Discipline of Regulatory Science for Medical Product Development
  • Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
  • Publisher : National Academies Press
  • Release Date : 2016-08-11
  • Total pages : 104
  • ISBN : 0123944082
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Summary : The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial ...

Encyclopedia of Analytical Science

Encyclopedia of Analytical Science
  • Author : Anonim
  • Publisher : Elsevier
  • Release Date : 2019-04-02
  • Total pages : 5109
  • ISBN : 0123944082
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Summary : The third edition of the Encyclopedia of Analytical Science is a definitive collection of articles covering the latest technologies in application areas such as medicine, environmental science, food science and geology. Meticulously organized, clearly written and fully interdisciplinary, the Encyclopedia of Analytical Science provides foundational knowledge across the scope of ...

Drug Discovery Toxicology

Drug Discovery Toxicology
  • Author : Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy
  • Publisher : John Wiley & Sons
  • Release Date : 2016-03-22
  • 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 ...

Haschek and Rousseaux s Handbook of Toxicologic Pathology

Haschek and Rousseaux s Handbook of Toxicologic Pathology
  • Author : Wanda M. Haschek,Colin G. Rousseaux,Matthew A. Wallig,Brad Bolon
  • Publisher : Academic Press
  • Release Date : 2021-10-20
  • Total pages : 1152
  • ISBN : 0123944082
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Summary : Haschek and Rousseaux's Handbook of Toxicologic Pathology: Volume 1: Principles and Practice of Toxicologic Pathology is a key reference on the integration of structure and functional changes in tissues associated with the response to pharmaceuticals, chemicals and biologics. Volume 1 of the Fourth Edition covers the practice of toxicologic pathology in three ...

Comprehensive Biomarker Discovery and Validation for Clinical Application

Comprehensive Biomarker Discovery and Validation for Clinical Application
  • Author : Péter Horvatovich,Rainer Bischoff
  • Publisher : Royal Society of Chemistry
  • Release Date : 2013-06-17
  • Total pages : 320
  • ISBN : 0123944082
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Summary : This book focuses on proteomics biomarker discovery and validation procedures from the clinical perspective. It provides an overview of current technology and the challenges encountered throughout the process. This covers all key stages, from biomarker discovery and validation, through to registration with the European and US regulatory authorities (FDA and ...