Development And Application Of Biomarkers
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Biomarkers In Drug Development
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Author : Michael R. Bleavins
language : en
Publisher: John Wiley & Sons
Release Date : 2011-09-20
Biomarkers In Drug Development written by Michael R. Bleavins and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-09-20 with Medical categories.
Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.
Development And Application Of Biomarkers
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Author : Roger L. Lundblad
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Development And Application Of Biomarkers written by Roger L. Lundblad and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
First introduced to biomedical research in 1980, the term biomarker has taken on a life of its own in recent years and has come to mean a number of things. In biomedical science, biomarker has evolved to most commonly mean a characteristic that can be used either as a diagnostic or a prognostic, but most significantly as a screening indicator for p
Comprehensive Biomarker Discovery And Validation For Clinical Application
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Author : Péter Horvatovich
language : en
Publisher: Royal Society of Chemistry
Release Date : 2013
Comprehensive Biomarker Discovery And Validation For Clinical Application written by Péter Horvatovich and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with Medical categories.
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 (EMEA and FDA). All the important elements (such as patient selection, sample handling, data processing, and statistical analysis) are described in detail and the reader is introduced to each topic with well described examples or guidelines for best practice. Case studies are also included to demonstrate clinical applications. Individual chapters explain the best performing techniques for profiling complex body fluids and biomarker discovery. This includes the application of different LC-MS profiling platforms and affinity array for screening complex body fluids. Future developments needed to improve the success rate of translating biomarker discovery into useful clinical tests are also discussed. Common pitfalls and success stories are described as are the limitations of the various technologies involved. Broad and interdisciplinary in approach, this book provides an excellent source of information for industrial and academic researchers.
Imaging Biomarkers
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Author : Luis Martí-Bonmatí
language : en
Publisher: Springer
Release Date : 2016-11-03
Imaging Biomarkers written by Luis Martí-Bonmatí and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-03 with Medical categories.
This is the first book to cover all aspects of the development of imaging biomarkers and their integration into clinical practice, from the conceptual basis through to the technical aspects that need to be considered in order to ensure that medical imaging can serve as a powerful quantification instrument capable of providing valuable information on organ and tissue properties. The process of imaging biomarker development is considered step by step, covering proof of concept, proof of mechanism, image acquisition, image preparation, imaging biomarker analysis and measurement, detection of measurement biases (proof of principle), proof of efficacy and effectiveness, and reporting of results. Sources of uncertainty in the accuracy and precision of measurements and pearls and pitfalls in gold standards and biological correlation are discussed. In addition, practical use cases are included on imaging biomarker implementation in brain, oncologic, cardiovascular, musculoskeletal, and abdominal diseases. The authors are a multidisciplinary team of expert radiologists and engineers, and the book will be of value to all with an interest in the quantitative imaging of biomarkers in personalized medicine.
The Detection Of Biomarkers
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Author : Sibel A. Ozkan
language : en
Publisher: Academic Press
Release Date : 2021-12-05
The Detection Of Biomarkers written by Sibel A. Ozkan and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-12-05 with Medical categories.
Reliable, precise and accurate detection and analysis of biomarkers remains a significant challenge for clinical researchers. Methods for the detection of biomarkers are rather complex, requiring pre-treatment steps before analysis can take place. Moreover, comparing various biomarker assays and tracing research progress in this area systematically is a challenge for researchers. The Detection of Biomarkers presents developments in biomarker detection, including methods tools and strategies, biosensor design, materials, and applications. The book presents methods, materials and procedures that are simple, precise, sensitive, selective, fast and economical, and therefore highly practical for use in clinical research scenarios. This volume situates biomarker detection in its research context and sets out future prospects for the area. Its 20 chapters offer a comprehensive coverage of biomarkers, including progress on nanotechnology, biosensor types, synthesis, immobilization, and applications in various fields. The book also demonstrates, for students, how to synthesize and immobilize biosensors for biomarker assay. It offers researchers real alternative and innovative ways to think about the field of biomarker detection, increasing the reliability, precision and accuracy of biomarker detection. - Locates biomarker detection in its research context, setting out present and future prospects - Allows clinical researchers to compare various biomarker assays systematically - Presents new methods, materials and procedures that are simple, precise, sensitive, selective, fast and economical - Gives innovative biomarker assays that are viable alternatives to current complex methods - Helps clinical researchers who need reliable, precise and accurate biomarker detection methods
Biomarkers In Clinical Drug Development
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Author : John Bloom
language : en
Publisher: CRC Press
Release Date : 2003-05-20
Biomarkers In Clinical Drug Development written by John Bloom and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-05-20 with Medical categories.
Presenting applications in clinical development, pharmacokinetic/ pharmacodynamic modelling and clinical trial simulation, this reference studies the role of biomarkers in successful drug formulation and development.
Application Of Biomarkers In Cancer Epidemiology
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Author : P. Toniolo
language : en
Publisher:
Release Date : 1997
Application Of Biomarkers In Cancer Epidemiology written by P. Toniolo and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997 with Medical categories.
This publication originates from an international workshop which addresses a range of methodological issues underlying the use of biological markers of exposure, biological effects and individual susceptibility in cancer epidemiology. It includes a report of the workshop, with a general discussion and recommendation on epidemiology. a series of peer-reviewed authored contributors provide a more personal view on the most important aspects by key researchers.
Biomarkers In Drug Discovery And Development
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Author : Ramin Rahbari
language : en
Publisher: John Wiley & Sons
Release Date : 2020-02-28
Biomarkers In Drug Discovery And Development written by Ramin Rahbari and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-02-28 with Medical categories.
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 development timelines and costs, enable selection of better compounds and reduce late stage attrition, and facilitate personalized medicine Helps readers get a better understanding of biomarkers and how to use them, for example which are accepted by regulators and which still non-validated and exploratory Updates developments in genomic sequencing, and application of large data sets into pre-clinical and clinical testing; and adds new material on data mining, economics, and decision making, personal genetic tools, and wearable monitoring Includes case studies of biomarkers that have helped and hindered decision making Reviews of the first edition: "If you are interested in biomarkers, and it is difficult to imagine anyone reading this who wouldn't be, then this book is for you." (ISSX) and "...provides a good introduction for those new to the area, and yet it can also serve as a detailed reference manual for those practically involved in biomarker implementation." (ChemMedChem)
The Handbook Of Biomarkers
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Author : Kewal K. Jain
language : en
Publisher: Humana Press
Release Date : 2017-09-16
The Handbook Of Biomarkers written by Kewal K. Jain and has been published by Humana Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-16 with Science categories.
Involved in nearly every therapeutic area, particularly cancer, biomarkers have experienced tremendous advances since the first edition of this book, both in the discovery of biomarkers and in their applications. To aid in this imperative research, Prof. Kewal K. Jain’s Handbook of Biomarkers, Second Edition features a full revision and additional chapters to thoroughly describe many different types of biomarkers and their discovery using various "-omics" technologies, along with the background information needed for the evaluation of biomarkers as well as the essential procedures for their validation and use in clinical trials. With biomarkers described first according to technologies and then according to various diseases, this detailed book features the key correlations between diseases and classifications of biomarkers, which provides the reader with a guide to sort out current and future biomarkers. Comprehensive and cutting-edge, The Handbook of Biomarkers, Second Edition serves as a vital guide to furthering our understanding of biomarkers, which, by facilitating the combination of therapeutics with diagnostics, promise to play an important role in the development of personalized medicine, one of the most important trends in healthcare today.
Accelerating The Development Of Biomarkers For Drug Safety
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2009-07-20
Accelerating The Development Of Biomarkers For Drug Safety written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-07-20 with Medical categories.
Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.