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 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 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 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 Biomonitors and Biomarkers as Indicators of Environmental Change 2 written by Frank M. Butterworth and published by Springer Science & Business Media. This book was released on 2012-02-02 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: Monitoring the environment is absolutely essential if we are to identify hazards to human health, to assess environmental cleanup efforts, and to prevent further degradation of the ecosystem. Biomonitors and biomarkers combined with chemical monitoring offer the only approach to making these assessments. Based on an International Association of Great Lakes Research conference, this book is intended for researchers who want to incorporate new and different technologies in their development of specifically-crafted monitors; students who are learning the field of biomonitoring; and regulatory agencies that want to consider newer technologies to replace inadequate and less powerful test regimes.
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 in Toxicology written by Ramesh C Gupta and published by Academic Press. This book was released on 2019-02-13 with total page 1248 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomarkers in Toxicology, Second Edition, is a timely and comprehensive reference dedicated to all aspects of biomarkers that relate to chemical exposure and their effects on biological systems. This revised and completely updated edition includes both vertebrate and non-vertebrate species models for toxicological testing and the development of biomarkers. Divided into several key sections, this reference volume contains new chapters devoted to topics in microplastics, neuroimmunotoxicity and nutraceuticals, along with a look at the latest cutting-edge technologies used to detect biomarkers. Each chapter contains several references to current literature and important resources for further reading. Given this comprehensive treatment, this book is an essential reference for anyone interested in biomarkers across the scientific and biomedical fields. - Evaluates the expansive literature, providing one resource covering all aspects of toxicology biomarkers - Includes completely revised chapters, along with additional chapters on the newest developments in the field - Identifies and discusses the most sensitive, accurate, unique and validated biomarkers used as indicators of exposure - Covers special topics and applications of biomarkers, including chapters on molecular toxicology biomarkers, biomarker analysis for nanotoxicology, development of biomarkers for drug efficacy evaluation, and much more
Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2011-10-25 with total page 673 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design. - Provides extensive coverage of the "study schema" and related features of study design - Offers a "hands-on" reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design - Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design - Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials - Includes chapters on core material and important ancillary topics, such as package inserts, consent forms, and safety reporting forms used in the United States, England and Europe - For complimentary access to our sample chapter (chapter 24), please copy and paste this link into your browser: http://tinyurl.com/awwutvn
Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2016-02-19 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. - Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more - Extensively covers the "study schema" and related features of study design - Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials - Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
Download or read book The Handbook of Metabonomics and Metabolomics written by John C. Lindon and published by Elsevier. This book was released on 2011-08-11 with total page 573 pages. Available in PDF, EPUB and Kindle. Book excerpt: Molecular biology operates at three levels – genes, proteins and metabolites. This book is unique in that it provides a comprehensive description of an approach (metabonomics) to characterise the endogenous metabolites in a living system, complementing gene and protein studies (genomics and proteomics). These "omics" methods form the basis for understanding biology at a systems level. The Handbook of Metabonomics and Metabolomics aims to be the definitive work on the rapidly expanding subjects of metabolic profiling, metabolite and biomarker identification, encompassing the fields of metabonomics and metabolomics. It covers the principles of the subject, the analytical and statistical techniques used and the wide variety of applications.* comprehensive description of an approach (metabonomics) to characterise the endogenous metabolites in a living system, complementing gene and protein studies* aims to be the definitive work on the rapidly expanding subjects of metabolic profiling, metabolite and biomarker identification* covers the principles of the subject, the analytical and statistical techniques used and the wide variety of applications.
Download or read book Handbook of Practical Immunohistochemistry written by Fan Lin and published by Springer. This book was released on 2015-02-21 with total page 756 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a conceptually current, quick-reference, Question & Answer format, the second edition of Handbook of Practical Immunohistochemistry: Frequently Asked Questions continues to provide a comprehensive and yet concise state-of-the-art overview of the major issues specific to the field of immunohistochemistry. With links to the authors Immunohistochemical Laboratory website, this volume creates a current and up-to-date information system on immunohistochemistry. This includes access to tissue microarrays (TMA) of over 10,000 tumors and normal tissue to validate common diagnostic panels and provide the best reproducible data for diagnostic purposes. Fully revised and updated from the first edition, the new features of the second edition include over 200 additional questions or revised questions with an IHC panel to answer each question; over 250 new color photos and illustrations; over 20 new useful biomarkers; hundreds of new references; several new chapters to cover phosphoproteins, rabbit monoclonal antibodies, multiplex IHC stains, overview of predictive biomarkers, and integration of IHC into molecular pathology; many new coauthors who are international experts in a related field; many updated IHC panels using Geisinger IHC data collected from over 10,000 tumors and normal tissues; and updated appendices containing detailed antibody information for both manual and automated staining procedures. Comprehensive yet practical and concise, the Handbook of Practical Immunohistochemistry: Frequently Asked Questions, Second Edition will be of great value for surgical pathologists, pathology residents and fellows, cytopathologists, and cytotechnologists.
Download or read book Targeted Biomarker Quantitation by LC MS written by Naidong Weng and published by John Wiley & Sons. This book was released on 2017-07-31 with total page 397 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first book to offer a blueprint for overcoming the challenges to successfully quantifying biomarkers in living organisms The demand among scientists and clinicians for targeted quantitation experiments has experienced explosive growth in recent years. While there are a few books dedicated to bioanalysis and biomarkers in general, until now there were none devoted exclusively to addressing critical issues surrounding this area of intense research. Target Biomarker Quantitation by LC-MS provides a detailed blueprint for quantifying biomarkers in biological systems. It uses numerous real-world cases to exemplify key concepts, all of which were carefully selected and presented so as to allow the concepts they embody to be easily expanded to future applications, including new biomarker development. Target Biomarker Quantitation by LC-MS primarily focuses on the assay establishment for biomarker quantitation—a critical issue rarely treated in depth. It offers comprehensive coverage of three core areas of biomarker assay establishment: the relationship between the measured biomarkers and their intended usage; contemporary regulatory requirements for biomarker assays (a thorough understanding of which is essential to producing a successful and defendable submission); and the technical challenges of analyzing biomarkers produced inside a living organism or cell. Covers the theory of and applications for state-of-the-art mass spectrometry and chromatography and their applications in biomarker analysis Features real-life examples illustrating the challenges involved in target biomarker quantitation and the innovative approaches which have been used to overcome those challenges Addresses potential obstacles to obtain effective biomarker level and data interpretation, such as specificity establishment and sample collection Outlines a tiered approach and fit-for-purpose assay protocol for target biomarker quantitation Highlights the current state of the biomarker regulatory environment and protocol standards Target Biomarker Quantitation by LC-MS is a valuable resource for bioanalytical scientists, drug metabolism and pharmacokinetics scientists, clinical scientists, analytical chemists, and others for whom biomarker quantitation is an important tool of the trade. It also functions as an excellent text for graduate courses in pharmaceutical, biochemistry and chemistry.
Download or read book ESMO Handbook of Cancer Diagnosis and Treatment Evaluation written by Hans-Joachim Schmoll and published by CRC Press. This book was released on 2009-02-20 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt: An informative handbook on the staging of cancer and the selection and evaluation of cancer treatment. ESMO Handbook on Treatment Evaluation in Cancer is an ideal resource for medical oncologists and those involved in screening and chemotherapy programs. The text demonstrates how to judge various prognostic and predictive factors, how to determine
Download or read book Handbook of Diagnostic Endocrinology written by William Winter E and published by Academic Press. This book was released on 2020-10-06 with total page 747 pages. Available in PDF, EPUB and Kindle. Book excerpt: The clinical laboratory plays a critical role in the diagnosis and management of endocrine and related metabolic disorders, which are leading causes of morbidity and mortality in children and adults. The Handbook of Diagnostic Endocrinology, Third Edition, provides a ready reference for the evaluation, diagnosis, and monitoring of such disorders. This revision incorporates translational medicine, connecting what clinicians need to know with those in research providing a clinical context to which they can relate their molecular findings. This book solves the needs of clinicians and researchers by bringing together in one book endocrinology at the molecular and clinical levels. As the intricacies of intracellular signaling have become better understood, states of hormone resistance are now increasingly recognized. The most common endocrinopathy in westernized countries, the metabolic syndrome, results, to a large extent, from insulin resistance. The complexity of the circulating forms of various hormones are acknowledged in this revision. - Each chapter focuses on the biochemical tests that are required, either in the basal state or following provocation or suppression, to assist in the diagnosis of the various disorders - Describes proper sample collection and relevant interpretations of laboratory tests - Contains essential molecular biology and incorporates it with the clinical information - Includes the discovery of new diagnostic and treatment methods
Download or read book Monitoring Metabolic Status written by Institute of Medicine and published by National Academies Press. This book was released on 2004-08-29 with total page 469 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Oxford Handbook of Oncology written by Jim Cassidy and published by Oxford University Press, USA. This book was released on 2015 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide to clinical consultation in oncology has been extensively revised and updated. It reflects recent advances in oncology with particular emphasis on new therapies and the emergence of immunotherapy as a real modality.
Download or read book Clinical Trials Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2009-06-17 with total page 1247 pages. Available in PDF, EPUB and Kindle. Book excerpt: Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.
