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Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309157277
Category : Medical
Languages : en
Pages : 335
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Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309157277
Category : Medical
Languages : en
Pages : 335
Get Book Here
Book Description
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.
Author: Tomasz Burzykowski
Publisher: Springer Science & Business Media
ISBN: 0387270809
Category : Medical
Languages : en
Pages : 417
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Book Description
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.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309462568
Category : Medical
Languages : en
Pages : 335
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Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309151295
Category : Medical
Languages : en
Pages : 334
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Book Description
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.
Author: Committee on Qualifications of Biomarkers and Surrogate Endpoints in Chronic Disease
Publisher:
ISBN: 9780309384537
Category :
Languages : en
Pages : 334
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Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309163242
Category : Medical
Languages : en
Pages : 140
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Book Description
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.
Author: Michael R. Bleavins
Publisher: John Wiley & Sons
ISBN: 1118210425
Category : Medical
Languages : en
Pages : 559
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Book Description
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.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 030946482X
Category : Medical
Languages : en
Pages : 287
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Book Description
What foods should Americans eat to promote their health, and in what amounts? What is the scientific evidence that supports specific recommendations for dietary intake to reduce the risk of multifactorial chronic disease? These questions are critically important because dietary intake has been recognized to have a role as a key determinant of health. As the primary federal source of consistent, evidence-based information on dietary practices for optimal nutrition, the Dietary Guidelines for Americans (DGA) have the promise to empower Americans to make informed decisions about what and how much they eat to improve health and reduce the risk of chronic disease. The adoption and widespread translation of the DGA requires that they be universally viewed as valid, evidence-based, and free of bias and conflicts of interest to the extent possible. However, this has not routinely been the case. A first short report meant to inform the 2020 review cycle explored how the advisory committee selection process can be improved to provide more transparency, eliminate bias, and include committee members with a range of viewpoints. This second and final report recommends changes to the DGA process to reduce and manage sources of bias and conflicts of interest, improve timely opportunities for engagement by all interested parties, enhance transparency, and strengthen the science base of the process.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309488346
Category : Medical
Languages : en
Pages : 595
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Book Description
As essential nutrients, sodium and potassium contribute to the fundamentals of physiology and pathology of human health and disease. In clinical settings, these are two important blood electrolytes, are frequently measured and influence care decisions. Yet, blood electrolyte concentrations are usually not influenced by dietary intake, as kidney and hormone systems carefully regulate blood values. Over the years, increasing evidence suggests that sodium and potassium intake patterns of children and adults influence long-term population health mostly through complex relationships among dietary intake, blood pressure and cardiovascular health. The public health importance of understanding these relationships, based upon the best available evidence and establishing recommendations to support the development of population clinical practice guidelines and medical care of patients is clear. This report reviews evidence on the relationship between sodium and potassium intakes and indicators of adequacy, toxicity, and chronic disease. It updates the Dietary Reference Intakes (DRIs) using an expanded DRI model that includes consideration of chronic disease endpoints, and outlines research gaps to address the uncertainties identified in the process of deriving the reference values and evaluating public health implications.
Author: Chetan Trivedy
Publisher: CRC Press
ISBN: 0340985011
Category : Medical
Languages : en
Pages : 771
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Book Description
This book is a dedicated resource for those sitting the Part A of the MCEM (Membership of the College of Emergency Medicine) examination. It forms an essential revision guide for emergency trainees who need to acquire a broad understanding of the basic sciences, which underpin their approach to clinical problems in the emergency department. Common clinical scenarios are used to highlight the essential underlying basic science principles, providing a link between clinical management and a knowledge of the underlying anatomical, physiological, pathological and biochemical processes. Multiple choice questions with reasoned answers are used to confirm the candidates understanding and for self testing. Unlike other recent revision books which provide MCQ questions with extended answers, this book uses clinical cases linked to the most recent basic science aspects of the CEM syllabus to provide a book that not only serves as a useful revision resource for the Part A component of the MCEM examination, but also a unique way of understanding the processes underlying common clinical cases seen every day in the emergency department. This book is essential for trainees sitting the Part A of the MCEM exam and for clinicians and medical students who need to refresh their knowledge of basic sciences relevant to the management of clinical emergencies.
