Download or read book Analysis of Biomarker Data written by Stephen W. Looney and published by John Wiley & Sons. This book was released on 2015-03-16 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Biomarker Analysis in Clinical Trials with R written by Nusrat Rabbee and published by CRC Press. This book was released on 2020-03-11 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt: The world is awash in data. This volume of data will continue to increase. In the pharmaceutical industry, much of this data explosion has happened around biomarker data. Great statisticians are needed to derive understanding from these data. This book will guide you as you begin the journey into communicating, understanding and synthesizing biomarker data. -From the Foreword, Jared Christensen, Vice President, Biostatistics Early Clinical Development, Pfizer, Inc. Biomarker Analysis in Clinical Trials with R offers practical guidance to statisticians in the pharmaceutical industry on how to incorporate biomarker data analysis in clinical trial studies. The book discusses the appropriate statistical methods for evaluating pharmacodynamic, predictive and surrogate biomarkers for delivering increased value in the drug development process. The topic of combining multiple biomarkers to predict drug response using machine learning is covered. Featuring copious reproducible code and examples in R, the book helps students, researchers and biostatisticians get started in tackling the hard problems of designing and analyzing trials with biomarkers. Features: Analysis of pharmacodynamic biomarkers for lending evidence target modulation. Design and analysis of trials with a predictive biomarker. Framework for analyzing surrogate biomarkers. Methods for combining multiple biomarkers to predict treatment response. Offers a biomarker statistical analysis plan. R code, data and models are given for each part: including regression models for survival and longitudinal data, as well as statistical learning models, such as graphical models and penalized regression models.
Download or read book Bioinformatics and Biomarker Discovery written by Francisco Azuaje and published by John Wiley & Sons. This book was released on 2011-08-24 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is designed to introduce biologists, clinicians and computational researchers to fundamental data analysis principles, techniques and tools for supporting the discovery of biomarkers and the implementation of diagnostic/prognostic systems. The focus of the book is on how fundamental statistical and data mining approaches can support biomarker discovery and evaluation, emphasising applications based on different types of "omic" data. The book also discusses design factors, requirements and techniques for disease screening, diagnostic and prognostic applications. Readers are provided with the knowledge needed to assess the requirements, computational approaches and outputs in disease biomarker research. Commentaries from guest experts are also included, containing detailed discussions of methodologies and applications based on specific types of "omic" data, as well as their integration. Covers the main range of data sources currently used for biomarker discovery Covers the main range of data sources currently used for biomarker discovery Puts emphasis on concepts, design principles and methodologies that can be extended or tailored to more specific applications Offers principles and methods for assessing the bioinformatic/biostatistic limitations, strengths and challenges in biomarker discovery studies Discusses systems biology approaches and applications Includes expert chapter commentaries to further discuss relevance of techniques, summarize biological/clinical implications and provide alternative interpretations
Download or read book Neuroscience Biomarkers and Biosignatures written by Institute of Medicine and published by National Academies Press. This book was released on 2008-01-08 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomarkers, or biological markers, are quantitative measurements that offer researchers and clinicians valuable insight into diagnosis, treatment and prognosis for many disorders and diseases. A major goal in neuroscience medical research is establishing biomarkers for disorders of the nervous system. Given the promising potential and necessity for neuroscience biomarkers, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened a public workshop and released the workshop summary entitled Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships. The workshop brought together experts from multiple areas to discuss the most promising and practical arenas in neuroscience in which biomarkers will have the greatest impact. The main objective of the workshop was to identify and discuss biomarker targets that are not currently being aggressively pursued but that could have the greatest near-term impact on the rate at which new treatments are brought forward for psychiatric and neurological disorders.
Download or read book Proteomic and Metabolomic Approaches to Biomarker Discovery written by Haleem J. Issaq and published by Academic Press. This book was released on 2013-05-20 with total page 489 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proteomic and Metabolomic Approaches to Biomarker Discovery demonstrates how to leverage biomarkers to improve accuracy and reduce errors in research. Disease biomarker discovery is one of the most vibrant and important areas of research today, as the identification of reliable biomarkers has an enormous impact on disease diagnosis, selection of treatment regimens, and therapeutic monitoring. Various techniques are used in the biomarker discovery process, including techniques used in proteomics, the study of the proteins that make up an organism, and metabolomics, the study of chemical fingerprints created from cellular processes. Proteomic and Metabolomic Approaches to Biomarker Discovery is the only publication that covers techniques from both proteomics and metabolomics and includes all steps involved in biomarker discovery, from study design to study execution. The book describes methods, and presents a standard operating procedure for sample selection, preparation, and storage, as well as data analysis and modeling. This new standard effectively eliminates the differing methodologies used in studies and creates a unified approach. Readers will learn the advantages and disadvantages of the various techniques discussed, as well as potential difficulties inherent to all steps in the biomarker discovery process. A vital resource for biochemists, biologists, analytical chemists, bioanalytical chemists, clinical and medical technicians, researchers in pharmaceuticals, and graduate students, Proteomic and Metabolomic Approaches to Biomarker Discovery provides the information needed to reduce clinical error in the execution of research. - Describes the use of biomarkers to reduce clinical errors in research - Includes techniques from a range of biomarker discoveries - Covers all steps involved in biomarker discovery, from study design to study execution
Download or read book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease written by Institute of Medicine and published by National Academies Press. This book was released on 2010-06-25 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The Detection of Biomarkers written by Sibel A. Ozkan and published by Academic Press. This book was released on 2021-12-05 with total page 615 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Biomarkers in Drug Development written by Michael R. Bleavins and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 559 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Evolution of Translational Omics written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-13 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Metabolic Profiling Its Role in Biomarker Discovery and Gene Function Analysis written by George G. Harrigan and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is evident that biochemical control is not strictly hierarchical and that intermediary metabolism can contribute to control of regulatory pathways. Metabolic studies are therefore increasingly important in gene function analyses, and an increased interest in metabolites as biomarkers for disease progression or response to therapeutic intervention is also evident in the pharmaceutical industry. This book offers guidelines to currently available technology and bioinformatics and database strategies now being developed. Evidence is presented that metabolic profiling is a valuable addition to genomics and proteomics strategies devoted to drug discovery and development, and that metabolic profiling offers numerous advantages.
Download or read book Accelerating the Development of Biomarkers for Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2009-07-20 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Biosocial Surveys written by National Research Council and published by National Academies Press. This book was released on 2008-01-06 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biosocial Surveys analyzes the latest research on the increasing number of multipurpose household surveys that collect biological data along with the more familiar interviewerâ€"respondent information. This book serves as a follow-up to the 2003 volume, Cells and Surveys: Should Biological Measures Be Included in Social Science Research? and asks these questions: What have the social sciences, especially demography, learned from those efforts and the greater interdisciplinary communication that has resulted from them? Which biological or genetic information has proven most useful to researchers? How can better models be developed to help integrate biological and social science information in ways that can broaden scientific understanding? This volume contains a collection of 17 papers by distinguished experts in demography, biology, economics, epidemiology, and survey methodology. It is an invaluable sourcebook for social and behavioral science researchers who are working with biosocial data.
Download or read book The Biomarker Guide written by K. E. Peters and published by Cambridge University Press. This book was released on 2005 with total page 489 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of The Biomarker Guide is a fully updated and expanded version of this essential reference. Now in two volumes, it provides a comprehensive account of the role that biomarker technology plays both in petroleum exploration and in understanding Earth history and processes. Biomarkers and Isotopes in the Environment and Human History details the origins of biomarkers and introduces basic chemical principles relevant to their study. It discusses analytical techniques, and applications of biomarkers to environmental and archaeological problems. The Biomarker Guide is an invaluable resource for geologists, petroleum geochemists, biogeochemists, environmental scientists and archaeologists.
Download or read book Biomarkers of Human Aging written by Alexey Moskalev and published by . This book was released on 2019 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book collects and reviews, for the first time, a wide range of advances in the area of human aging biomarkers. This accumulated data allows researchers to assess the rate of aging processes in various organs and systems, and to individually monitor the effectiveness of therapies intended to slow aging. In an introductory chapter, the editor defines biomarkers of aging as molecular, cellular and physiological parameters that demonstrate reproducible changes - quantitative or qualitative - with age. The introduction recounts a study which aimed to create a universal model of biological age, whose most predictive parameters were albumin and alkaline phosphatase (indication liver function), glucose (metabolic syndrome), erythrocytes (respiratory function) and urea (renal function). The book goes on to describe DNA methylation, known as the "epigenetic clock," as currently the most comprehensive predictor of total mortality. It is also useful for predicting mortality from cancer and cardiovascular diseases, and for analyzing the effects of lifestyle factors including diet, exercise, and education. Individual contributions draw additional insight from research on genetics and epigenetic aging markers, and immunosenescence and inflammaging markers. A concluding chapter outlines the challenge of integrating of biological and clinical markers of aging. Biomarkers of Human Aging is written for professionals and practitioners engaged in the study of aging, and will be useful to both advanced students and researchers.
Download or read book Comprehensive Biomarker Discovery and Validation for Clinical Application written by Péter Horvatovich and published by Royal Society of Chemistry. This book was released on 2013-06-17 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 (FDA and EMEA). 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 mass spectrometry imaging combined with chromatography in profiling platforms and the use of laser micro dissection and MALDI imaging to study tissues in their natural environment. 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, and those managing biobanks.
Download or read book The Statistical Evaluation of Medical Tests for Classification and Prediction written by Margaret Sullivan Pepe and published by OUP Oxford. This book was released on 2003-03-13 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The Evaluation of Surrogate Endpoints written by Geert Molenberghs and published by Springer Science & Business Media. This book was released on 2005-02-28 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
