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This is the first book to cover all aspects of the development of imaging biomarkers and their integration into clinical practice, from the conceptual basis through to the technical aspects that need to be considered in order to ensure that medical imaging can serve as a powerful quantification instrument capable of providing valuable information on organ and tissue properties. The process of imaging biomarker development is considered step by step, covering proof of concept, proof of mechanism, image acquisition, image preparation, imaging biomarker analysis and measurement, detection of measurement biases (proof of principle), proof of efficacy and effectiveness, and reporting of results. Sources of uncertainty in the accuracy and precision of measurements and pearls and pitfalls in gold standards and biological correlation are discussed. In addition, practical use cases are included on imaging biomarker implementation in brain, oncologic, cardiovascular, musculoskeletal, and abdominal diseases. The authors are a multidisciplinary team of expert radiologists and engineers, and the book will be of value to all with an interest in the quantitative imaging of biomarkers in personalized medicine.
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.
Assembles world-class expertise on clinical and molecular imaging-derived biomarkers, presenting neuroimaging in epilepsy in a broad neuroscientific context.
Quantitative Magnetic Resonance Imaging is a 'go-to' reference for methods and applications of quantitative magnetic resonance imaging, with specific sections on Relaxometry, Perfusion, and Diffusion. Each section will start with an explanation of the basic techniques for mapping the tissue property in question, including a description of the challenges that arise when using these basic approaches. For properties which can be measured in multiple ways, each of these basic methods will be described in separate chapters. Following the basics, a chapter in each section presents more advanced and recently proposed techniques for quantitative tissue property mapping, with a concluding chapter on clinical applications. The reader will learn: - The basic physics behind tissue property mapping - How to implement basic pulse sequences for the quantitative measurement of tissue properties - The strengths and limitations to the basic and more rapid methods for mapping the magnetic relaxation properties T1, T2, and T2* - The pros and cons for different approaches to mapping perfusion - The methods of Diffusion-weighted imaging and how this approach can be used to generate diffusion tensor - maps and more complex representations of diffusion - How flow, magneto-electric tissue property, fat fraction, exchange, elastography, and temperature mapping are performed - How fast imaging approaches including parallel imaging, compressed sensing, and Magnetic Resonance - Fingerprinting can be used to accelerate or improve tissue property mapping schemes - How tissue property mapping is used clinically in different organs - Structured to cater for MRI researchers and graduate students with a wide variety of backgrounds - Explains basic methods for quantitatively measuring tissue properties with MRI - including T1, T2, perfusion, diffusion, fat and iron fraction, elastography, flow, susceptibility - enabling the implementation of pulse sequences to perform measurements - Shows the limitations of the techniques and explains the challenges to the clinical adoption of these traditional methods, presenting the latest research in rapid quantitative imaging which has the possibility to tackle these challenges - Each section contains a chapter explaining the basics of novel ideas for quantitative mapping, such as compressed sensing and Magnetic Resonance Fingerprinting-based approaches
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.
This volume presents recent data on the latest achievements in new and emerging technologies for biomarkers and for innovations in their assessment. The chapters cover topics such as activation of microglia and macrophages in neurodegenerative diseases; oxidative stress and cellular dysfunction in neurodegenerative diseases; TSPO PET imaging as a biomarker of neuroinflammation in neurodegenerative disorders; and imaging biomarkers in Huntington's disease and amyotrophic lateral sclerosis. In the Neuromethods series style, chapters include the kind of detail and key advice from the specialists needed to get successful results in your laboratory. Cutting-edge and comprehensive, Neurodegenerative Diseases Biomarkers: Towards Translating Research to Clinical Practice is a valuable resource for both experimental and clinical experts in the field of neurodegenerative diseases who are looking to expand their knowledge of novel biomarkers in different types of neurodegenerative diseases.
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.
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.
This book provides a thorough overview of the ongoing evolution in the application of artificial intelligence (AI) within healthcare and radiology, enabling readers to gain a deeper insight into the technological background of AI and the impacts of new and emerging technologies on medical imaging. After an introduction on game changers in radiology, such as deep learning technology, the technological evolution of AI in computing science and medical image computing is described, with explanation of basic principles and the types and subtypes of AI. Subsequent sections address the use of imaging biomarkers, the development and validation of AI applications, and various aspects and issues relating to the growing role of big data in radiology. Diverse real-life clinical applications of AI are then outlined for different body parts, demonstrating their ability to add value to daily radiology practices. The concluding section focuses on the impact of AI on radiology and the implications for radiologists, for example with respect to training. Written by radiologists and IT professionals, the book will be of high value for radiologists, medical/clinical physicists, IT specialists, and imaging informatics professionals.
Epilepsy is a prevalent and serious neurological disorder. This vital textbook addresses the role of neuroimaging as a unique tool to provide in vivo biomarkers aimed at furthering our understanding of causes and consequences of epilepsy in a day-to-day clinical context. Unique in its approach, this translational book presents a critical appraisal of advanced pre-clinical biomarkers that allows capturing epileptogenesis at molecular, cellular, and neuronal system levels. The book is divided into four sections. Part I includes a series of chapters focused on imaging of early disease stages. Part II discusses lesion detection and network analysis methods. Part III focuses on imaging methods used to predict response to antiepileptic drugs and surgery. Finally, Part IV presents imaging techniques used to evaluate disease consequence.