Trends on the Role of PET in Drug Development


Book Description

Drug development is very expensive and a fight against time. PET offers possibilities to speed up this process by adding unique in vivo information on pharmacokinetics/dynamics of a drug at an early stage. This information can help decision makers to move the drug in the drug development process or to decide to stop further developments. This unique and complete book highlights the different ways PET can be used and describes the latest trends in the various disciplines within nuclear medicine to further improve methodologies and increase the number of tools to accelerate drug development. Various topics within tracer development, instrumentation, data analysis and many clinical and preclinical topics are described by leading scientists from industry and academia.




Handbook of Radiopharmaceuticals


Book Description

The thoroughly updated new edition of the authoritative reference in Radiopharmaceutical Sciences The second edition of Handbook of Radiopharmaceuticals is a comprehensive review of the field, presenting up-to-date coverage of central topics such as radionuclide production, synthetic methodology, radiopharmaceutical development and regulations, and a wide range of practical applications. A valuable reference work for those new to the Radiopharmaceutical Sciences and experienced professionals alike, this volume explores the latest concepts and issues involving both targeted diagnostic and therapeutic radiopharmaceuticals. Contributions from a team of experts from across sub-disciplines provide readers with an immersive examination of radiochemistry, nuclear medicine, molecular imaging, and more. Since the first edition of the Handbook was published, Nuclear Medicine and Radiopharmaceutical Sciences have undergone major changes. New radiopharmaceuticals for diagnosis and therapy have been approved by the FDA, the number of clinical PET and SPECT scans have increased significantly, and advances in Artificial Intelligence have dramatically improved research techniques. This fully revised edition reflects the current state of the field and features substantially updated and expanded content. New chapters cover topics including current Good Manufacturing Practice (cGMP), regulatory oversight, novel approaches to quality control—ensuring that readers are informed of the exciting developments of recent years. This important resource: Features extensive new and revised content throughout Covers key areas of application for diagnosis and therapy in oncology, neurology, and cardiology Emphasizes the multidisciplinary nature of Radiopharmaceutical Sciences Discusses how drug companies are using modern radiopharmaceutical imaging techniques to support drug discovery Examines current and emerging applications of Positron Emission Tomography (PET) and Single Photon Emission Computed Tomography (SPECT) Edited by recognized experts in radiochemistry and PET imaging, Handbook of Radiopharmaceuticals: Radiochemistry and Applications, 2 nd Edition is an indispensable reference for post-doctoral fellows, research scientists, and professionals in the pharmaceutical industry, and for academics, graduate students, and newcomers in the field of radiopharmaceuticals.




Improving and Accelerating Therapeutic Development for Nervous System Disorders


Book Description

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.




The Use of Drugs in Food Animals


Book Description

The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.




Advancing Nuclear Medicine Through Innovation


Book Description

Nearly 20 million nuclear medicine procedures are carried out each year in the United States alone to diagnose and treat cancers, cardiovascular disease, and certain neurological disorders. Many of the advancements in nuclear medicine have been the result of research investments made during the past 50 years where these procedures are now a routine part of clinical care. Although nuclear medicine plays an important role in biomedical research and disease management, its promise is only beginning to be realized. Advancing Nuclear Medicine Through Innovation highlights the exciting emerging opportunities in nuclear medicine, which include assessing the efficacy of new drugs in development, individualizing treatment to the patient, and understanding the biology of human diseases. Health care and pharmaceutical professionals will be most interested in this book's examination of the challenges the field faces and its recommendations for ways to reduce these impediments.




Critical Needs for Research in Veterinary Science


Book Description

Research in veterinary science is critical for the health and well-being of animals, including humans. Food safety, emerging infectious diseases, the development of new therapies, and the possibility of bioterrorism are examples of issues addressed by veterinary science that have an impact on both human and animal health. However, there is a lack of scientists engaged in veterinary research. Too few veterinarians pursue research careers, and there is a shortage of facilities and funding for conducting research. This report identifies questions and issues that veterinary research can help to address, and discusses the scientific expertise and infrastructure needed to meet the most critical research needs. The report finds that there is an urgent need to provide adequate resources for investigators, training programs, and facilities involved in veterinary research.




PET/CT in Infection and Inflammation


Book Description

This pocket book provides clinicians with the necessary information to understand the role of FDG PET/CT in infection and inflammation. It will help both in making appropriate imaging requests with adequate clinical information and in interpreting the report. The coverage encompasses a wide range of topics, including the role of PET/CT in pyrexia of unknown origin, vasculitis, autoimmune diseases, prosthetic joint infections, osteomyelitis and diabetic foot, immunodeficiency disease, and vascular graft surgery. The book will be a very useful guide to a great test that can provide significant assistance in patient management. It is published within the Springer series Clinicians’ Guides to Radionuclide Hybrid Imaging, in which leading professionals succinctly explain the importance of nuclear medicine in the diagnosis and management of oncological and non-oncological conditions.




Molecular Imaging


Book Description

Radioisotope-based molecular imaging probes provide unprecedented insight into biochemistry and function involved in both normal and disease states of living systems, with unbiased in vivo measurement of regional radiotracer activities offering very high specificity and sensitivity. No other molecular imaging technology including functional magnetic resonance imaging (fMRI) can provide such high sensitivity and specificity at a tracer level. The applications of this technology can be very broad ranging from drug development, pharmacokinetics, clinical investigations, and finally to routine diagnostics in radiology. The design and the development of radiopharmaceuticals for molecular imaging studies using PET/MicroPET or SPECT/MicroSPECT are a unique challenge. This book is intended for a broad audience and written with the main purpose of educating the reader on various aspects including potential clinical utility, limitations of drug development, and regulatory compliance and approvals.




Biomarkers in Drug Development


Book Description

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.




Radioguided Surgery


Book Description

This multidisciplinary textbook is designed to be the standard on the subject and is geared for use by physicians who are involved in the care and/or diagnosis of cancer patients. Comprehensive coverage is provided on all aspects of radioguided surgery. Practical information is readily accessible and throughout there is an emphasis on improved decision making. Tables present the indications, performance, and interpretation of procedures at a glance. A wealth of illustrations, including a full-color insert, enhances the application of new concepts.