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Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309110122
Category : Medical
Languages : en
Pages : 150
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Book Description
In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to be $1.3 billion (DiMasi and Grabowski, 2007). At the same time, each year fewer new molecular entities (NMEs) are approved. DiMasi and Grabowski report that only 21.5 percent of the candidate drugs that enter phase I clinical testing actually make it to market. In 2007, just 17 novel drugs and 2 novel biologics were approved. In addition to the slowing rate of drug development and approval, recent years have seen a number of drugs withdrawn from the market for safety reasons. According to the Government Accountability Office (GAO), 10 drugs were withdrawn because of safety concerns between 2000 and March 2006 (GAO, 2006). Finding ways to select successful drug candidates earlier in development could save millions or even billions of dollars, reduce the costs of drugs on the market, and increase the number of new drugs with improved safety profiles that are available to patients. Emerging scientific knowledge and technologies hold the potential to enhance correct decision making for the advancement of candidate drugs. Identification of safety problems is a key reason that new drug development is stalled. Traditional methods for assessing a drug's safety prior to approval are limited in their ability to detect rare safety problems. Prior to receiving U.S. Food and Drug Administration (FDA) approval, a drug will have been tested in hundreds to thousands of patients. Generally, drugs cannot confidently be linked to safety problems until they have been tested in tens of thousands to hundreds of thousands of people. With current methods, it is unlikely that rare safety problems will be identified prior to approval. Emerging Safety Science: Workshop Summary summarizes the events and presentations of the workshop.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309110122
Category : Medical
Languages : en
Pages : 150
Get Book Here
Book Description
In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to be $1.3 billion (DiMasi and Grabowski, 2007). At the same time, each year fewer new molecular entities (NMEs) are approved. DiMasi and Grabowski report that only 21.5 percent of the candidate drugs that enter phase I clinical testing actually make it to market. In 2007, just 17 novel drugs and 2 novel biologics were approved. In addition to the slowing rate of drug development and approval, recent years have seen a number of drugs withdrawn from the market for safety reasons. According to the Government Accountability Office (GAO), 10 drugs were withdrawn because of safety concerns between 2000 and March 2006 (GAO, 2006). Finding ways to select successful drug candidates earlier in development could save millions or even billions of dollars, reduce the costs of drugs on the market, and increase the number of new drugs with improved safety profiles that are available to patients. Emerging scientific knowledge and technologies hold the potential to enhance correct decision making for the advancement of candidate drugs. Identification of safety problems is a key reason that new drug development is stalled. Traditional methods for assessing a drug's safety prior to approval are limited in their ability to detect rare safety problems. Prior to receiving U.S. Food and Drug Administration (FDA) approval, a drug will have been tested in hundreds to thousands of patients. Generally, drugs cannot confidently be linked to safety problems until they have been tested in tens of thousands to hundreds of thousands of people. With current methods, it is unlikely that rare safety problems will be identified prior to approval. Emerging Safety Science: Workshop Summary summarizes the events and presentations of the workshop.
Author: Steven Ricke
Publisher: Academic Press
ISBN: 0128004045
Category : Technology & Engineering
Languages : en
Pages : 466
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Book Description
Food Safety: Emerging Issues, Technologies and Systems offers a systems approach to learning how to understand and address some of the major complex issues that have emerged in the food industry. The book is broad in coverage and provides a foundation for a practical understanding in food safety initiatives and safety rules, how to deal with whole-chain traceability issues, handling complex computer systems and data, foodborne pathogen detection, production and processing compliance issues, safety education, and more. Recent scientific industry developments are written by experts in the field and explained in a manner to improve awareness, education and communication of these issues. - Examines effective control measures and molecular techniques for understanding specific pathogens - Presents GFSI implementation concepts and issues to aid in implementation - Demonstrates how operation processes can achieve a specific level of microbial reduction in food - Offers tools for validating microbial data collected during processing to reduce or eliminate microorganisms in foods
Author: Eugene Williams
Publisher: Nova Science Publishers
ISBN: 9781536107463
Category : Medical care
Languages : en
Pages : 0
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Book Description
The harm associated with health care is a questionable issue and several systemic global strategies to reduce it with a safer system are being developed. Despite these efforts, errors continue to happen and one of the most important challenges is to become aware of its real dimension and process-occurrence. This book provides new research on patient safety and management. It discusses different perspectives, principles and reviews emerging issues in the medical field.
Author: Rani Lill Anjum
Publisher: Springer Nature
ISBN: 3030412393
Category : Philosophy
Languages : en
Pages : 252
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Book Description
This open access book is a unique resource for health professionals who are interested in understanding the philosophical foundations of their daily practice. It provides tools for untangling the motivations and rationality behind the way medicine and healthcare is studied, evaluated and practiced. In particular, it illustrates the impact that thinking about causation, complexity and evidence has on the clinical encounter. The book shows how medicine is grounded in philosophical assumptions that could at least be challenged. By engaging with ideas that have shaped the medical profession, clinicians are empowered to actively take part in setting the premises for their own practice and knowledge development. Written in an engaging and accessible style, with contributions from experienced clinicians, this book presents a new philosophical framework that takes causal complexity, individual variation and medical uniqueness as default expectations for health and illness.
Author: Professor Robert L Wears
Publisher: Ashgate Publishing, Ltd.
ISBN: 1472469194
Category : Medical
Languages : en
Pages : 297
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Book Description
Properly performing health care systems require concepts and methods that match their complexity. Resilience engineering provides that capability. It focuses on a system’s overall ability to sustain required operations under both expected and unexpected conditions rather than on individual features or qualities. This book contains contributions from international experts in health care, organisational studies and patient safety, as well as resilience engineering. Whereas current safety approaches primarily aim to reduce the number of things that go wrong, Resilient Health Care aims to increase the number of things that go right.
Author: Ashok Vaseashta
Publisher: Springer Nature
ISBN: 3030760081
Category : Technology & Engineering
Languages : en
Pages : 731
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Book Description
This book focuses on threats, especially contaminants, to drinking water and the supply system, especially in municipalities but also in industrial and even residential settings. The safety, security, and suitability landscape can be described as dynamic and complex stemming from necessity and hence culpability due to the emerging threats and risks, vis-a-vis globalization resulting in new forms of contaminants being used due to new technologies. The book provides knowledge and guidance for engineers, scientists, designers, researchers, and students who are involved in water, sustainability, and study of security issues. This book starts out with basics of water usage, current statistics, and an overview ofwater resources. The book then introduces different scenarios of safety and security and areas that researchers need to focus. Following that, the book presents different types of contaminants – inadvertent, intentional, or incidental. The next section presents different methodologies of contamination sensing/detection and remediation strategies as per guidance and standards set globally. The book then concludes with selected chapters on water management, including critical infrastructure that is critical to maintaining safe water supplies to cities and municipalities. Each chapter includes descriptive information for professionals in their respective fields. The breadth of chapters offers insights into how science (physical, natural, and social) and technology can support new developments to manage the complexity resident within the evolving threat and risk landscape.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309300940
Category : Science
Languages : en
Pages : 162
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Book Description
Recent serious and sometimes fatal accidents in chemical research laboratories at United States universities have driven government agencies, professional societies, industries, and universities themselves to examine the culture of safety in research laboratories. These incidents have triggered a broader discussion of how serious incidents can be prevented in the future and how best to train researchers and emergency personnel to respond appropriately when incidents do occur. As the priority placed on safety increases, many institutions have expressed a desire to go beyond simple compliance with regulations to work toward fostering a strong, positive safety culture: affirming a constant commitment to safety throughout their institutions, while integrating safety as an essential element in the daily work of laboratory researchers. Safe Science takes on this challenge. This report examines the culture of safety in research institutions and makes recommendations for university leadership, laboratory researchers, and environmental health and safety professionals to support safety as a core value of their institutions. The report discusses ways to fulfill that commitment through prioritizing funding for safety equipment and training, as well as making safety an ongoing operational priority. A strong, positive safety culture arises not because of a set of rules but because of a constant commitment to safety throughout an organization. Such a culture supports the free exchange of safety information, emphasizes learning and improvement, and assigns greater importance to solving problems than to placing blame. High importance is assigned to safety at all times, not just when it is convenient or does not threaten personal or institutional productivity goals. Safe Science will be a guide to make the changes needed at all levels to protect students, researchers, and staff.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309132967
Category : Medical
Languages : en
Pages : 359
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Book Description
Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.
Author: Michael E. Knowles
Publisher: Elsevier
ISBN: 0128194707
Category : Medical
Languages : en
Pages : 1188
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Book Description
Present Knowledge in Food Safety: A Risk-Based Approach Through the Food Chain presents approaches for exposure-led risk assessment and the management of changes in the chemical, pathogenic microbiological and physical (radioactivity) contamination of 'food' at all key stages of production, from farm to consumption. This single volume resource introduces scientific advances at all stages of the production to improve reliability, predictability and relevance of food safety assessments for the protection of public health. This book is aimed at a diverse audience, including graduate and post-graduate students in food science, toxicology, microbiology, medicine, public health, and related fields. The book's reach also includes government agencies, industrial scientists, and policymakers involved in food risk analysis. Includes new technologies such as nanotechnology, genetic modification, and cloning Provides information on advances in pathogen risk assessment through novel and real-time molecular biological techniques, biomarkers, resistance measurement, and cell-to-cell communication in the gut Covers the role of the microbiome and the use of surrogates (especially for viruses)
Author: Committee on Halcion: An Assessment of Data Adequacy and Confidence
Publisher: National Academies Press
ISBN: 0309591457
Category : Medical
Languages : en
Pages : 177
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Book Description
Regulatory agencies within the United States and the United Kingdom, among several other countries, have reviewed extensively the safety and efficacy of Halcion (triazolam)--a once commonly used hypnotic drug. Concerns began to emerge about the safety of Halcion when a Dutch physician reported a possible link between it and a syndrome that included such effects as depression, amnesia, hallucinations, and increased anxiety. In addition, in 1991 its manufacturer, Upjohn, noted that "errors had been identified in a report of one of the clinical studies included in the original" application for approval. Since then, the drug has been removed from the market in several countries, whereas in the United States and Canada, the drug's labeling has been modified to reduce the recommended dose and duration of treatment and to heighten awareness of possible side effects. Yet different data and analyses have resulted in conflicting messages that are difficult to reconcile and interpret. In response to a request from the Food and Drug Administration to resolve these controversial issues related to the safety and efficacy of Halcion, this IOM book assesses the adequacy of the drug's clinical trials; the quality and quantity of data on adverse reactions; overall confidence in the data on effectiveness, adverse events, and side effects at different doses; and whether additional studies are needed.
