Seventh Annual Focused Issue On Methods In Safety Pharmacology
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| Author | : Michael K. Pugsley |
| Publisher | : Springer |
| Total Pages | : 477 |
| Release | : 2015-06-19 |
| Genre | : Medical |
| ISBN | : 366246943X |
This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.
| Author | : National Academies of Sciences, Engineering, and Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 473 |
| Release | : 2015-12-29 |
| Genre | : Medical |
| ISBN | : 0309377722 |
Getting the right diagnosis is a key aspect of health care - it provides an explanation of a patient's health problem and informs subsequent health care decisions. The diagnostic process is a complex, collaborative activity that involves clinical reasoning and information gathering to determine a patient's health problem. According to Improving Diagnosis in Health Care, diagnostic errors-inaccurate or delayed diagnoses-persist throughout all settings of care and continue to harm an unacceptable number of patients. It is likely that most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences. Diagnostic errors may cause harm to patients by preventing or delaying appropriate treatment, providing unnecessary or harmful treatment, or resulting in psychological or financial repercussions. The committee concluded that improving the diagnostic process is not only possible, but also represents a moral, professional, and public health imperative. Improving Diagnosis in Health Care, a continuation of the landmark Institute of Medicine reports To Err Is Human (2000) and Crossing the Quality Chasm (2001), finds that diagnosis-and, in particular, the occurrence of diagnostic errorsâ€"has been largely unappreciated in efforts to improve the quality and safety of health care. Without a dedicated focus on improving diagnosis, diagnostic errors will likely worsen as the delivery of health care and the diagnostic process continue to increase in complexity. Just as the diagnostic process is a collaborative activity, improving diagnosis will require collaboration and a widespread commitment to change among health care professionals, health care organizations, patients and their families, researchers, and policy makers. The recommendations of Improving Diagnosis in Health Care contribute to the growing momentum for change in this crucial area of health care quality and safety.
| Author | : National Academies of Sciences, Engineering, and Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 483 |
| Release | : 2017-09-28 |
| Genre | : Medical |
| ISBN | : 0309459575 |
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
| Author | : Agency for Healthcare Research and Quality/AHRQ |
| Publisher | : Government Printing Office |
| Total Pages | : 385 |
| Release | : 2014-04-01 |
| Genre | : Medical |
| ISBN | : 1587634333 |
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 241 |
| Release | : 1990-02-01 |
| Genre | : Medical |
| ISBN | : 0309042860 |
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
| Author | : Ali S. Faqi |
| Publisher | : Academic Press |
| Total Pages | : 903 |
| Release | : 2012-10-18 |
| Genre | : Medical |
| ISBN | : 0123878160 |
A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. - Chapters written by world-renowned contributors who are experts in their fields - Includes the latest research in preclinical drug testing and international guidelines - Covers preclinical toxicology in small molecules and biologics in one single source
| Author | : Andreas Müller |
| Publisher | : Springer Nature |
| Total Pages | : 622 |
| Release | : 2022-04-22 |
| Genre | : Technology & Engineering |
| ISBN | : 3031048709 |
This book presents the proceedings of the 31st International Conference on Robotics in Alpe-Adria-Danube Region (RAAD), held in Klagenfurt, Austria, June 8-10, 2022. It gathers contributions by researchers from several countries on all major areas of robotic research, development and innovation, as well as new applications and current trends. The topics covered include: novel designs and applications of robotic systems, intelligent cooperating and service robots, advanced robot control, human-robot interfaces, robot vision systems, mobile robots, humanoid and walking robots, bio-inspired and swarm robotic systems, aerial, underwater and spatial robots, robots for ambient assisted living, medical robots and bionic prostheses, cognitive robots, cloud robotics, ethical and social issues in robotics, etc. Given its scope, the book offers a source of information and inspiration for researchers seeking to improve their work and gather new ideas for future developments. Chapter “The Use of Robots in Aquatic Biomonitoring with Special Focus on Biohybrid Entities” is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.
| Author | : Hugh MacPherson |
| Publisher | : Elsevier Health Sciences |
| Total Pages | : 288 |
| Release | : 2007-10-12 |
| Genre | : Medical |
| ISBN | : 0443100292 |
This is the first book to set out a full range of research strategies for evaluating the clinical practice of acupuncture. Leading acupuncturists and researchers with international reputations share their expertise. They illustrate their descriptions with practical examples of what has worked and what has not. It outlines many of the key challenges in the field. These challenges relate to the nature of acupuncture and the gap between current research evidence and the actual experiences of acupuncturists in the field. By focusing the chapters on key research questions, rather than methods, the book has a user-friendly feel. Each chapter is easily accessible with brief explanations of research designs as well as vignettes of relevant past research. The book is based on a deep understanding of acupuncture, with its inherent complexity in practice, whether based on traditional principles or more modern concepts. By incorporating a more sophisticated understanding of the field, this book details a range of strategies aiming to develop the evidence base with the utmost rigour. It is the first book on acupuncture research to take this unique view, integrating the very best of evidence-based medicine with a genuine sensitivity to the discipline of acupuncture, from its traditional and holistic roots to its more modern interpretations.
| Author | : John I. Gallin |
| Publisher | : Elsevier |
| Total Pages | : 447 |
| Release | : 2011-04-28 |
| Genre | : Science |
| ISBN | : 0080489567 |
The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 202 |
| Release | : 2008-09-06 |
| Genre | : Medical |
| ISBN | : 0309113695 |
Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership.
