Perspectives On Biomarker And Surrogate Endpoint Evaluation
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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.
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 : 2010-07-25
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 2010-07-25 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.
Pharmaco Imaging In Drug And Biologics Development
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Author : Brian R. Moyer
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-11-08
Pharmaco Imaging In Drug And Biologics Development written by Brian R. Moyer 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 2013-11-08 with Medical categories.
The volume aim to be a comprehensive overview of the drug and biologic development process that is often called “the valley of death” (pre-IND through approval) where high costs of studies and high rates of product failure are part of the drug development landscape. Imaging tools can serve in this period by adding high value data, the images and the kinetic information they can provide, and cost-effective development alternative tools which potentially improve pivotal study designs. Imaging may identify safety issues early such as unwanted organ or tissue distributions, and then can serve advanced development with added certainty of a drug or biologic’s success to senior corporate management and investors. There are numerous textbooks, reference texts and treatises on medical imaging technologies, teaching tools on medical cases and physics books on the science of detector and computer interface systems. Rarely, in each of these are examples of medical imaging protocols and animal models of disease i.e. a text on methodology in drug development is currently unavailable.
Science And The Citizen
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Author : Marco Mamone Capria
language : en
Publisher: Lulu.com
Release Date : 2013-06-07
Science And The Citizen written by Marco Mamone Capria and has been published by Lulu.com this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-06-07 with Reference categories.
This collection of essays comes from the international project "Science and Democracy". It offers an examination of several controversial issues, within and about science, of wide-ranging social relevance. A partial list runs as follows: the role of scientific technology in shaping our life; the influence of corporations on contemporary medicine; grass-roots activism and new technologies; environmental constraints on economical growth; the HIV/AIDS controversy; the Wakefield trial and the MMR vaccine-autism link; the organ transplant ideology and business; the debate on the terrorist attacks in USA of September 11, 2001; the role of whistleblowers in science; etc. - Contributions by J. Barretto Bastos Filho, H. Bauer, M. Brown, M. C. Danhoni Neves, F. Fabbri, P. Ghisellini, S. Lang, A. Liversidge, C. Loré, M. Mamone Capria, R. Maruotti, D. Mastrangelo, S. Maurano, M. Mazzucco, D. Rasnick, S. Siminovic, S. Ulgiati, M. Walker.
Oxford Textbook Of Neuroscience And Anaesthesiology
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Author : George A. Mashour
language : en
Publisher: Oxford University Press
Release Date : 2019-01-10
Oxford Textbook Of Neuroscience And Anaesthesiology written by George A. Mashour and has been published by Oxford University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-01-10 with Medical categories.
The perioperative care of individuals with neurologic compromise is critically important, yet it is only one dimension of the rich relationship between anaesthesiology and the neurosciences. The mechanism of everyday therapeutic interventions such as anaesthesia and analgesia is exciting neuroscience in its own right. At the new frontier of outcomes studies lies the question of how the perioperative period might impact the brain. For example, questions related to anaesthetic neurotoxicity, delirium, and cognitive dysfunction pose critical challenges for the field. The Oxford Textbook in Neuroscience and Anaesthesiology addresses the exciting field of neuroanaesthesiology in a new and stimulating way. In twenty eight chapters, the neuroscientific basis of anaesthesiology, the full spectrum of clinical neuroanaesthesia, and the care of neurologic patients undergoing non-neurologic surgery are explored in one comprehensive textbook for the first time. The first section considers the neural mechanisms of general anaesthetics, cerebral physiology, the neurobiology of pain, and more. The second section explores the care of patients with neurologic disease in the operating room or intensive care unit. These clinical chapters systematically treat the perioperative considerations of both brain and spine surgery, and provide introductions to neurocritical care and pediatric neuroanaesthesia. The final section outlines the care of neurologic patients undergoing non-neurologic surgery. It examines key connections of neurology and anaesthesiology, examining how conditions such as dementia, stroke, or epilepsy interface with the perioperative period. Each chapter has been carefully crafted to be concise yet highly informative, reflecting the cutting edge of neuroscience and neuroanaesthesiology. This international textbook gathers the best available expertise of authors and leaders worldwide. Includes access to online-only content, including more than 20 cases and more than 90 questions that can be used in presentations and teaching sessions. By activating your unique access code, you can access and use the material.
Science Is Not What You Think
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Author : Henry H. Bauer
language : en
Publisher: McFarland
Release Date : 2017-06-26
Science Is Not What You Think written by Henry H. Bauer and has been published by McFarland this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-06-26 with Reference categories.
This book discusses the ways in which science, the touchstone of reliable knowledge in modern society, changed dramatically in the second half of the 20th century, becoming less trustworthy through conflicts of interest and excessive competitiveness. Fraud became common enough that organized efforts to combat it now include a federal Office of Research Integrity. Competent minority opinions are sometimes thereby suppressed, with the result that policy makers, the media and the public are presented with biased or incomplete information. Evidence tending to challenge established theories is sometimes rejected without addressing its substance. While most would agree in the abstract that science can go wrong, few would consider--despite interesting contrary evidence--that official consensus about the origins of the universe or the causes of global warming might be mistaken.
Neuromonitoring Techniques
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Author : Hemanshu Prabhakar
language : en
Publisher: Academic Press
Release Date : 2017-11-13
Neuromonitoring Techniques written by Hemanshu Prabhakar and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-13 with Medical categories.
Neuromonitoring Techniques: Quick Guide for Clinicians and Residents provides a quick and easy guide to understanding various neuromonitoring equipment. Chapters include intracranial pressure monitoring, EEG-based monitors, evoked potentials and transcranial doppler. This book is written for trainees, clinicians and researchers in the fields of neurosurgery, neurocritical care, neuroradiology, neuroanesthesia and neurology. As specialized neuromonitoring is now routinely done in neurosurgical cases, it provides an important resource for neurologists, neurophysiologists, anesthesiologists and residents who are expected to have theoretical and practical knowledge on different systems. Each monitoring system is discussed separately, with examples, images, reference values and their interpretations. - Provides a quick and easy guide to understanding various neuromonitoring techniques - Presents information on each monitoring system, with examples, images, reference values and their interpretation - Useful for trainees, clinicians and researchers in the fields of neurosurgery, neurocritical care, neuroradiology, neuroanasthesia and neurology
Informing The Future
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-10-12
Informing The Future 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 2011-10-12 with Medical categories.
This report illustrates the work of IOM committees in selected, major areas in recent years, followed by a description of IOM's convening and collaborative activities and fellowship programs. The last section provides a comprehensive bibliography of IOM reports published since 2007.
Analysis Of Biomarker Data
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Author : Stephen W. Looney
language : en
Publisher: John Wiley & Sons
Release Date : 2015-01-23
Analysis Of Biomarker Data written by Stephen W. Looney 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 2015-01-23 with Medical categories.
A “how to” guide for applying statistical methods to biomarker data analysis Presenting a solid foundation for the statistical methods that are used to analyze biomarker data, Analysis of Biomarker Data: A Practical Guide features preferred techniques for biomarker validation. The authors provide descriptions of select elementary statistical methods that are traditionally used to analyze biomarker data with a focus on the proper application of each method, including necessary assumptions, software recommendations, and proper interpretation of computer output. In addition, the book discusses frequently encountered challenges in analyzing biomarker data and how to deal with them, methods for the quality assessment of biomarkers, and biomarker study designs. Covering a broad range of statistical methods that have been used to analyze biomarker data in published research studies, Analysis of Biomarker Data: A Practical Guide also features: A greater emphasis on the application of methods as opposed to the underlying statistical and mathematical theory The use of SAS®, R, and other software throughout to illustrate the presented calculations for each example Numerous exercises based on real-world data as well as solutions to the problems to aid in reader comprehension The principles of good research study design and the methods for assessing the quality of a newly proposed biomarker A companion website that includes a software appendix with multiple types of software and complete data sets from the book’s examples Analysis of Biomarker Data: A Practical Guide is an ideal upper-undergraduate and graduate-level textbook for courses in the biological or environmental sciences. An excellent reference for statisticians who routinely analyze and interpret biomarker data, the book is also useful for researchers who wish to perform their own analyses of biomarker data, such as toxicologists, pharmacologists, epidemiologists, environmental and clinical laboratory scientists, and other professionals in the health and environmental sciences.
Developments In Statistical Evaluation Of Clinical Trials
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Author : Kees van Montfort
language : en
Publisher: Springer
Release Date : 2014-10-07
Developments In Statistical Evaluation Of Clinical Trials written by Kees van Montfort and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-10-07 with Mathematics categories.
This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.