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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.
The second edition of The Biomarker Guide is a fully updated and expanded version of this essential reference.
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.
This textbook provides a unique and thorough look at the application of chemical biomarkers to aquatic ecosystems. Defining a chemical biomarker as a compound that can be linked to particular sources of organic matter identified in the sediment record, the book indicates that the application of these biomarkers for an understanding of aquatic ecosystems consists of a biogeochemical approach that has been quite successful but underused. This book offers a wide-ranging guide to the broad diversity of these chemical biomarkers, is the first to be structured around the compounds themselves, and examines them in a connected and comprehensive way. This timely book is appropriate for advanced undergraduate and graduate students seeking training in this area; researchers in biochemistry, organic geochemistry, and biogeochemistry; researchers working on aspects of organic cycling in aquatic ecosystems; and paleoceanographers, petroleum geologists, and ecologists. Provides a guide to the broad diversity of chemical biomarkers in aquatic environments The first textbook to be structured around the compounds themselves Describes the structure, biochemical synthesis, analysis, and reactivity of each class of biomarkers Offers a selection of relevant applications to aquatic systems, including lakes, rivers, estuaries, oceans, and paleoenvironments Demonstrates the utility of using organic molecules as tracers of processes occurring in aquatic ecosystems, both modern and ancient
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.
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.
Get a quick, expert overview of the ways in which biomarkers can be used to assess and guide the management of cardiovascular disease in the clinical setting. This concise, clinically-focused resource by Dr. Vijay Nambi consolidates today's available information on this rapidly changing topic into one convenient resource, making it an ideal, easy-to-digest reference for cardiology practitioners, fellows, and residents. - Covers lab standards and statistical interpretation of biomarkers with a clinical focus. - Discusses relevant conditions such as hypertension and diabetes as key markers of injury and prognosis. - Includes current information on biomarkers to assess and guide the management of heart failure, acute coronary syndrome, chest pain, shortness of breath, and more. - Concludes the book with a timely chapter on how biomarkers may guide cardiologists in the future.
Alcohol and Its Biomarkers: Clinical Aspects and Laboratory Determination is a concise guide to all currently known alcohol biomarkers, their clinical application, and the laboratory methods used to detect them. Pathologists can use this resource to understand the limitations and cost factors associated with each method for determining certain alcohol biomarkers. In addition, interferences in these determinations are discussed, so that clinicians can understand the causes of falsely elevated biomarkers and pathologists and laboratory scientists can potentially eliminate them. The book focuses on the analytical methods used to detect alcohol in blood and urine, the limitations of alcohol determination using enzymatic methods, and the differences between clinical and forensic alcohol measurement. Chapters also cover cutting-edge alcohol biomarkers for potential use. - Focuses on the analytical methods used for detecting alcohol in blood and urine along with the pitfalls and limitations of alcohol determination using enzymatic methods - Explains the difference between clinical and forensic alcohol measurement - Includes a brief overview of the benefits of consuming alcohol in moderation and the hazards of heavy drinking
"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.
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