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 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers proteomics biomarker discovery and validation procedures from the clinical perspective.

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 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 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 Handbook of Biomarkers and Precision Medicine written by Claudio Carini and published by CRC Press. This book was released on 2019-04-16 with total page 953 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development. Features: Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies Lessons-learned from successful Precision Medicine case studies A variety of exciting and emerging biomarker technologies The next frontiers and future challenges of biomarkers in Precision Medicine Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings’s College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.

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 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 Biomarkers in Cancer Screening and Early Detection written by Sudhir Srivastava and published by John Wiley & Sons. This book was released on 2017-08-28 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: Prepared by world leaders on this topic, Biomarkers in Cancer Screening and Early Detection offers a comprehensive, state-of-the-art perspective on the various research and clinical aspects of cancer biomarkers, from their discovery and development to their validation, clinical utility, and use in developing personalized cancer treatment. Offers a comprehensive, state-of-the-art perspective on the various research and clinical aspects of cancer biomarkers Provides immediately actionable information – and hopefully also inspiration – to move discovery and clinical application forward Offers vital knowledge to help develop personalized cancer treatment for individual patients with specific cancers

Download or read book The Handbook of Biomarkers written by Kewal K. Jain and published by Springer Science & Business Media. This book was released on 2010-02-06 with total page 509 pages. Available in PDF, EPUB and Kindle. Book excerpt: Of the thousands of biomarkers that are currently being discovered, relatively few are being validated for further applications, and the potential of a biomarker can be quite difficult to evaluate. To aid in this imperative research, Dr. Kewal K. Jain’s Handbook of Biomarkers thoroughly describes many different types of biomarkers and their discovery using various "-omics" technologies, such as proteomics and metabolomics, along with the background information needed for the evaluation of biomarkers as well as the essential procedures for their validation and use in clinical trials. With biomarkers described first according to technologies and then according to various diseases, this detailed book features the key correlations between diseases and classifications of biomarkers, which provides the reader with a guide to sort out current and future biomarkers. Comprehensive and cutting-edge, The Handbook of Biomarkers serves as a vital guide to furthering our understanding of biomarkers, which, by facilitating the combination of therapeutics with diagnostics, promise to play an important role in the development of personalized medicine, one of the most important emerging trends in healthcare today.

Download or read book Development and Application of Biomarkers written by Roger L. Lundblad and published by CRC Press. This book was released on 2016-04-19 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: First introduced to biomedical research in 1980, the term biomarker has taken on a life of its own in recent years and has come to mean a number of things. In biomedical science, biomarker has evolved to most commonly mean a characteristic that can be used either as a diagnostic or a prognostic, but most significantly as a screening indicator for p

Download or read book Statistical Analysis with Missing Data written by Roderick J. A. Little and published by John Wiley & Sons. This book was released on 2019-03-21 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: An up-to-date, comprehensive treatment of a classic text on missing data in statistics The topic of missing data has gained considerable attention in recent decades. This new edition by two acknowledged experts on the subject offers an up-to-date account of practical methodology for handling missing data problems. Blending theory and application, authors Roderick Little and Donald Rubin review historical approaches to the subject and describe simple methods for multivariate analysis with missing values. They then provide a coherent theory for analysis of problems based on likelihoods derived from statistical models for the data and the missing data mechanism, and then they apply the theory to a wide range of important missing data problems. Statistical Analysis with Missing Data, Third Edition starts by introducing readers to the subject and approaches toward solving it. It looks at the patterns and mechanisms that create the missing data, as well as a taxonomy of missing data. It then goes on to examine missing data in experiments, before discussing complete-case and available-case analysis, including weighting methods. The new edition expands its coverage to include recent work on topics such as nonresponse in sample surveys, causal inference, diagnostic methods, and sensitivity analysis, among a host of other topics. An updated “classic” written by renowned authorities on the subject Features over 150 exercises (including many new ones) Covers recent work on important methods like multiple imputation, robust alternatives to weighting, and Bayesian methods Revises previous topics based on past student feedback and class experience Contains an updated and expanded bibliography The authors were awarded The Karl Pearson Prize in 2017 by the International Statistical Institute, for a research contribution that has had profound influence on statistical theory, methodology or applications. Their work "has been no less than defining and transforming." (ISI) Statistical Analysis with Missing Data, Third Edition is an ideal textbook for upper undergraduate and/or beginning graduate level students of the subject. It is also an excellent source of information for applied statisticians and practitioners in government and industry.

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 Drug Discovery and Evaluation Methods in Clinical Pharmacology written by H.Gerhard Vogel and published by Springer Science & Business Media. This book was released on 2010-12-15 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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".

Download or read book General Methods in Biomarker Research and their Applications written by Victor R. Preedy and published by Springer. This book was released on 2015-08-14 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past decade there has been a major sea change in the way disease is diagnosed and investigated due to the advent of high throughput technologies, such as microarrays, lab on a chip, proteomics, genomics, lipomics, metabolomics etc. These advances have enabled the discovery of new and novel markers of disease relating to autoimmune disorders, cancers, endocrine diseases, genetic disorders, sensory damage, intestinal diseases etc. In many instances these developments have gone hand in hand with the discovery of biomarkers elucidated via traditional or conventional methods, such as histopathology or clinical biochemistry. Together with microprocessor-based data analysis, advanced statistics and bioinformatics these markers have been used to identify individuals with active disease or pathology as well as those who are refractory or have distinguishing pathologies. New analytical methods that have been used to identify markers of disease and is suggested that there may be as many as 40 different platforms. Unfortunately techniques and methods have not been readily transferable to other disease states and sometimes diagnosis still relies on single analytes rather than a cohort of markers. There is thus a demand for a comprehensive and focused evidenced-based text and scientific literature that addresses these issues. Hence the formulation of Biomarkers in Disease. The series covers a wide number of areas including for example, nutrition, cancer, endocrinology, cardiology, addictions, immunology, birth defects, genetics and so on. The chapters are written by national or international experts and specialists.

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 Companion and Complementary Diagnostics written by Jan Trøst Jørgensen and published by Academic Press. This book was released on 2019-05-08 with total page 509 pages. Available in PDF, EPUB and Kindle. Book excerpt: Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies. - Covers all aspects, from biomarker discovery, to development and regulatory approval - Explains the "how to" aspects of companion diagnostics - Incorporates information on the entire process, allowing for easier and deeper understanding of the topic

Download or read book Proteomics for Biomarker Discovery written by Virginie Brun and published by Humana Press. This book was released on 2019-05-04 with total page 293 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume presents modern and enhanced methods that detail techniques to perform proteomics analyses dedicated to biomarker discovery for human health. Chapters guide readers through pre/post analytical factors, protocols for the preparation of extracellular vesicles and exosomes, and various analytical pipelines including Data Independent Acquisition (DIA), discovery, as well as targeted and top-down proteomics analysis workflows. Bioinformatics tools and workflows to select and evaluate candidate biomarkers or combinations of biomarkers are also presented. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge, Proteomics for Biomarker Discovery: Methods and Protocols aims to ensure successful results in the further study of this vital field.