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This book covers two areas, the first detailing the concepts and technologies of drug-device combination products. The second area includes case studies of important products that either significantly shape our technologies and thinking, or contribute to current healthcare practice. The book: Discusses where drugs and devices work, where they fail, and when they need to work with each other Reviews interactions between human bodies and the drug-device combination products the measurements of these interactions Covers how a drug-device combination product is developed, tested, and regulated Includes case studies of steroid releasing leads, AOA treated tissue heart valves, intrathecal drug delivery pumps, infuse bone grafts, drug eluting stents, and antimicrobial meshes
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
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.
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.
Proteins are exposed to various interfacial stresses during drug product development. They are subjected to air-liquid, liquid-solid, and, sometimes, liquid-liquid interfaces throughout the development cycle-from manufacturing of drug substances to storage and drug delivery. Unlike small molecule drugs, proteins are typically unstable at interfaces where, on adsorption, they often denature and form aggregates, resulting in loss of efficacy and potential immunogenicity. This book covers both the fundamental aspects of proteins at interfaces and the quantification of interfacial behaviors of proteins. Importantly, this book introduces the industrial aspects of protein instabilities at interfaces, including the processes that introduce new interfaces, evaluation of interfacial instabilities, and mitigation strategies. The audience that this book targets encompasses scientists in the pharmaceutical and biotech industry, as well as faculty and students from academia in the surface science, pharmaceutical, and medicinal chemistry areas.
Acute pain has a physiological protective role in preventing tissue damage. However, pain can become chronic due to a multitude of pathophysiological states, such as: trauma, inflammation, neural injury, viral infection, cancer, autoimmune diseases and vascular and metabolic disorders. These pathological states can trigger alterations of the pain pathways that can lead to hypersensitivity, and in such circumstances, pain loses its protective role and instead, becomes persistent and debilitating affecting seriously to the quality of life of patients. Chronic pain is one of the most important health problems worldwide. It has been estimated that 10% of adults are diagnosed with chronic pain each year. However, despite the high prevalence of chronic pain, its management is still no fully satisfactory probably due to the variety of chronic pain conditions with different etiologies (neuropathic, visceral and musculoskeletal pain), and because their pathophysiological mechanisms are only partially known. Therefore, there is a huge need for new effective therapies for the control and/or prevention of the different types of chronic pain. Chronic pain is associated with plastic changes in pain circuits of the peripheral and central nervous system, including changes in the expression of ion channels, neurotransmitters and receptors. In addition, there is growing consensus on non-neuronal mechanisms that can amplify or resolve chronic pain, and cells traditionally thought to act just as coordinators of the inflammatory response (such as immune and glial cells) are now accepted as real modulators of pain signaling. In this regard, animal models of persistent pain, such as models of neuropathic and visceral pain and models of arthritis, are helping to elucidate our understanding of the pathogenesis of chronic pain and make it possible to test experimental treatments.
Higly efficient separation tools are increasingly required for satisfying the necessity of the modern society. In this context, for achieving optimized separation and purification of targeted compounds, the typical features of the imprinting technology and membrane science for developing the so-called imprinted membranes have been exploited. Imprinted membranes are smart systems endowing selective recognition properties towards specific molecules and ions that exhibit better performance with respect to the traditional separation techniques. The aim of this monography is to give a contribution in promoting the knowlegde on the current research trend about this topic. Starting from the concept of the molecular recognition the book introduces the reader to the fascinating world of the imprinting technology and membrane-based processes up to discussing the development of imprinted polymers as well as imprinted membranes, which represent their special format. The different imprinting strategies as well as the theory and mechanisms of the separation are also explained. Furthermore, the application of molecularly imprinted polymeric membranes in different areas for the selective recognition of drugs, active pharmaceutical ingredients, pesticides, other toxic compounds and proteins is discussed. The attention is also devoted to their employment in enantiomeric separation, sensors technology and controlled drug delivery. Finally, the production and application of ion imprinted membranes in the separation of metal ions, rare earth element and anions and the role of cyclodextrins in the imprinting technology are discussed.
Drug delivery systems represent a vast area of research and development within biomaterials and medicine and the demand for sophisticated drug delivery devices continues to drive novel product development. Advanced drug delivery devices can offer significant advantages over conventional drugs and devices alone, such as increased efficiency, improved performance and convenience. The purpose of this book is to illustrate how effective drug delivery can be achieved by means other than tablets. The book will provide a thorough analysis of the fundamentals, applications and new technologies of drug-device combination products for use throughout the human body.Part one provides readers with an introduction and background to the field. Chapters in Part two discuss areas of application such as catheter based products, drug eluting stents and beads and anti-biotic loaded cements. Part three covers the development of drug device combination products with chapters on such topics as pre-clinical testing, sterilisation, patent issues and regulation of drug device combination products.With its distinguished editor and team of international contributors, Drug-device combination products: delivery technologies and applications is an invaluable reference for product development specialists, materials scientists and engineers in the biomedical industry and academia as well as those concerned with drug delivery. - Illustrates how effective drug delivery can be achieved by means other than tablets providing readers with a comprehensive introduction and background to the field - Provides a thorough analysis of the fundamentals, applications and new technologies of drug device combination products - Discusses areas of application such as catheter based products and reviews the development of drug device combination products including pre-clinical testing and sterilisation
Cardiovascular, respiratory, and related conditions cause more than 40 percent of all deaths globally, and their substantial burden is rising, particularly in low- and middle-income countries (LMICs). Their burden extends well beyond health effects to include significant economic and societal consequences. Most of these conditions are related, share risk factors, and have common control measures at the clinical, population, and policy levels. Lives can be extended and improved when these diseases are prevented, detected, and managed. This volume summarizes current knowledge and presents evidence-based interventions that are effective, cost-effective, and scalable in LMICs.
Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodologies. The book begins with an overview of the design control process, integrating human factors as directed by AAMI TIR 59 and experienced practice. It then explains each method, describing why each method is important, its potential impact, when it's ideal to use, and related challenges. Also discussed are other barriers, such as communication breakdowns between users and design teams. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation. - Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU) - Explains technology development and the application of human factors throughout the development process - Covers FDA and MHRA regulations - Includes case examples with each method