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The U.S. military's concerns about the individual combat service member's ability to avoid performance degradation, in conjunction with the need to maintain both mental and physical capabilities in highly stressful situations, have led to and interest in developing methods by which commanders can monitor the status of the combat service members in the field. This report examines appropriate biological markers, monitoring technologies currently available and in need of development, and appropriate algorithms to interpret the data obtained in order to provide information for command decisions relative to the physiological "readiness" of each combat service member. More specifically, this report also provides responses to questions posed by the military relative to monitoring the metabolic regulation during prolonged, exhaustive efforts, where nutrition/hydration and repair mechanisms may be mismatched to intakes and rest, or where specific metabolic derangements are present.
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.
Built on a decade of experience with novel molecular diagnostics, this practice-oriented guide shows how to cope with validation issues during all stages of biomarker development, from the first clinical studies to the eventual commercialization of a new diagnostic test.
This book provides an introduction to the field of biomarkers, how they have been and can be used, and how different approaches can be used to identify, characterize, and monitor biomarkers. The book has chapters on topics including HIV, Cancer, Parkinson’s, vascular injury, environmental exposure. A following section discusses the technologies (diagnostics and assays) to detect biomarkers and authors have emphasized the preclinical and clinical manifestation of the injury/disease process.
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 the field of biomarker research and development in kidney diseases. The book is an ideal companion for those interested in biomarker research and development, proteomics and metabolomics, kidney diseases, statistical analysis, transplantation, and preeclampsia. New chapters include biomarkers of cardiovascular disease in patients with CKD, biomarkers of Polycystic Kidney Disease, and biomarkers and the role of nanomedicine. - Explores both the practical and conceptual steps performed in the discovery of biomarkers in kidney disease - Presents a comprehensive account of newer biomarker discover strategies, such as metabolomics and proteomics, all illustrated by clear examples - Offers clear translational presentations by the top basic and clinical researchers in each specific renal disease, including AKI, transplantation, cancer, CKD, PKD, diabetic nephropathy, preeclampsia, and glomerular disease
Since laboratory testing and biomarkers are an integral part in the diagnosis and treatment of kidney disease, Kidney Biomarkers: Clinical Aspects and Laboratory Determination covers currently used biomarkers as well as markers that are in development. Laboratories are increasingly more involved in the follow-up confirmatory laboratory testing and this unique volume showcases the collaboration needed to solve diagnostic clinical puzzles between the laboratory and clinician. This volume provides guidance on laboratory test selection and results interpretation in patients. Sources of inaccurate results in the measurement of kidney biomarkers are discussed along with possibility of eliminating such interferences. Each chapter is organized with a uniform easy-to-follow format with insightful case examples highlighting the collaboration between clinical laboratorians and clinicians. - Categorizes biomarkers into diagnostic markers, disease follow-up markers, and prognostic biomarkers - Include case examples to show the collaboration between the clinical laboratorian and clinician - Discusses the application of kidney biomarkers in clinical practice along with addressing laboratory aspects of kidney biomarker determination
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)
This book describes statistical techniques for the design and evaluation of research studies on medical diagnostic tests, screening tests, biomarkers and new technologies for classification and prediction in medicine.
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.
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.