Evaluation Of Biomarkers And Surrogate Endpoints In Chronic Disease
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Evaluation Of Biomarkers And Surrogate Endpoints In Chronic Disease
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2010-06-25
Evaluation Of Biomarkers And Surrogate Endpoints In Chronic Disease 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 2010-06-25 with Medical categories.
Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.
Perspectives On Biomarker And Surrogate Endpoint Evaluation
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-02-12
Perspectives On Biomarker And Surrogate Endpoint Evaluation 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 2011-02-12 with Medical categories.
In 2010 the Institute of Medicine (IOM) recommended a framework for the evaluation of biomarkers in the chronic disease setting. Published in the book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, the framework is intended to bring consistency and transparency to the previously disparate process of biomarker evaluation. Following the book's release, the IOM convened a 2-day discussion forum in Washington, DC, in order to provide an opportunity for stakeholders to learn about, react to, and discuss the book. Presentations reviewed the authoring committee's work process, recommendations, and provided perspectives on the book from the point of view of participants. Thomas Fleming, professor of biostatistics and statistics at the University of Washington, gave a keynote presentation on the critical issues in the validation of surrogate endpoints, a specific use of a biomarker. The present volume recounts the discussion forum proceedings, focusing in turn on each represented sector. A summary of Dr. Fleming's presentation then sets the committee's recommendations within the context of biomarker utilization. Lastly, this summary examines the main themes raised by stakeholders, and the challenges and opportunities presented to stakeholders by the book's recommendations.
The Evaluation Of Surrogate Endpoints
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Author : Tomasz Burzykowski
language : en
Publisher: Springer Science & Business Media
Release Date : 2005-11-24
The Evaluation Of Surrogate Endpoints written by Tomasz Burzykowski and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-11-24 with Medical categories.
Covers the latest research on a sensitive and controversial topic in a professional and well researched manner. Provides practical outlook as well as model guidelines and software tools that should be of interest to people who use the software tools described and those who do not. Related title by Co-author Geert Molenbergh has sold more than 3500 copies world wide. Provides dual viewpoints: from scientists in the industry as well as regulatory authorities.
Guiding Principles For Developing Dietary Reference Intakes Based On Chronic Disease
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2017-12-21
Guiding Principles For Developing Dietary Reference Intakes Based On Chronic Disease written by National Academies of Sciences, Engineering, and 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 2017-12-21 with Medical categories.
Since 1938 and 1941, nutrient intake recommendations have been issued to the public in Canada and the United States, respectively. Currently defined as the Dietary Reference Intakes (DRIs), these values are a set of standards established by consensus committees under the National Academies of Sciences, Engineering, and Medicine and used for planning and assessing diets of apparently healthy individuals and groups. In 2015, a multidisciplinary working group sponsored by the Canadian and U.S. government DRI steering committees convened to identify key scientific challenges encountered in the use of chronic disease endpoints to establish DRI values. Their report, Options for Basing Dietary Reference Intakes (DRIs) on Chronic Disease: Report from a Joint US-/Canadian-Sponsored Working Group, outlined and proposed ways to address conceptual and methodological challenges related to the work of future DRI Committees. This report assesses the options presented in the previous report and determines guiding principles for including chronic disease endpoints for food substances that will be used by future National Academies committees in establishing DRIs.
Evolution Of Translational Omics
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-09-13
Evolution Of Translational Omics 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 2012-09-13 with Science categories.
Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.
The Evaluation Of Surrogate Endpoints
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Author : Geert Molenberghs
language : en
Publisher: Springer Science & Business Media
Release Date : 2005-02-28
The Evaluation Of Surrogate Endpoints written by Geert Molenberghs and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-02-28 with Mathematics categories.
Covers the latest research on a sensitive and controversial topic in a professional and well researched manner. Provides practical outlook as well as model guidelines and software tools that should be of interest to people who use the software tools described and those who do not. Related title by Co-author Geert Molenbergh has sold more than 3500 copies world wide. Provides dual viewpoints: from scientists in the industry as well as regulatory authorities.
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.
Chagas Disease
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Author : Jaime Marcelo Altcheh
language : en
Publisher: Springer Nature
Release Date : 2019-09-09
Chagas Disease written by Jaime Marcelo Altcheh and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-09-09 with Science categories.
Chagas disease is a potentially life threatening condition that was historically mainly endemic to Latin America. Over the last decade, however, the disease has spread to and is increasingly prevalent in other continents such as North America and Europe, with an estimated 7 million people infected worldwide. It is primarily transmitted by insect vectors that carry the parasite Trypanosoma cruzi, the disease agent. In areas where there is vector control and in non-endemic countries, it is mainly transmitted via congenital infection. Cardiac and gastrointestinal complications are common in untreated individuals. This book offers a comprehensive overview of Chagas disease, including its vectorial and congenital transmission, and molecular diagnosis, which is essential for screening, and developing and providing timely, effective anti-trypanosomal treatment. Written by experts working with infected patients on a daily basis, it discusses the pathogenesis of congenital, cardiac, gastrointestinal and oral Chagas disease, as well as its treatment and the pharmacological aspects of drug development in this area. Chapter "Chagas Disease Treatment Efficacy Biomarkers: Myths and Realities" is available open access under a via link.springer.com.
Biomarkers For Traumatic Brain Injury
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Author : Svetlana Dambinova
language : en
Publisher: Royal Society of Chemistry
Release Date : 2012
Biomarkers For Traumatic Brain Injury written by Svetlana Dambinova 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 2012 with Medical categories.
Due to injuries sustained in sports and in combat, interest in traumatic brain injury (TBI) has never been greater. This book will fulfill a gap in understanding of what is occurring in the brain following injury that can subsequently be detected in biological fluids and imaging.
Drug Discovery And Evaluation Methods In Clinical Pharmacology
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Author : H.Gerhard Vogel
language : en
Publisher: Springer Science & Business Media
Release Date : 2010-12-15
Drug Discovery And Evaluation Methods In Clinical Pharmacology written by H.Gerhard Vogel and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-12-15 with Medical categories.
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 processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".