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Emerging Safety Science
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Book Synopsis Emerging Safety Science by : Institute of Medicine
Download or read book Emerging Safety Science written by Institute of Medicine and published by National Academies Press. This book was released on 2008-05-08 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 In addition to the slowing rate of drug development and approval, recent years have seen a number of drugs withdrawn from the market for safety reasons. According to the Government Accountability Office (GAO), 10 drugs were withdrawn because of safety concerns between 2000 and March 2006 (GAO, 2006).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.
Download or read book Food Safety written by Steven Ricke and published by Academic Press. This book was released on 2015-07-08 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development by : Institute of Medicine
Download or read book Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-04 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
Author :Indian National Science Academy Publisher :National Academies Press ISBN 13 :0309378699 Total Pages :215 pages Book Rating :4.3/5 (93 download)
Book Synopsis Indo-U.S. Workshop on Challenges of Emerging Infections and Global Health Safety by : Indian National Science Academy
Download or read book Indo-U.S. Workshop on Challenges of Emerging Infections and Global Health Safety written by Indian National Science Academy and published by National Academies Press. This book was released on 2016-05-13 with total page 215 pages. Available in PDF, EPUB and Kindle. Book excerpt: The United States and India have pledged to deepen the linkages between their people, their businesses, and their governments for the mutual benefit of both countries and for the promotion of global peace, stability, economic growth and prosperity. Both nations are now inclined to improve relations and cooperation, but the nations need specific actions that will yield progress and build confidence and momentum for further cooperation. The Indo-U.S. Workshop on Challenges of Emerging Infections and Global Health Safety, held in November 2014, encouraged scientists from both countries to examine global issues related to emerging and existing infections and global health safety, to share experience and approaches, and to identify opportunities for cooperation to improve practice and research in these areas. This report summarizes the presentations and discussions from the workshop.
Book Synopsis Patient Safety and Management by : Eugene Williams
Download or read book Patient Safety and Management written by Eugene Williams and published by Nova Science Publishers. This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Agriculture, Forestry, and Fishing Research at NIOSH by : Institute of Medicine
Download or read book Agriculture, Forestry, and Fishing Research at NIOSH written by Institute of Medicine and published by National Academies Press. This book was released on 2008-06-10 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: The agriculture, forestry, and fishing sectors are the cornerstone of industries that produce food, fiber, and biofuel. The National Institute for Occupational Safety and Health (NIOSH) conducts research in order to improve worker safety and health in these sectors. This National Research Council book reviews the NIOSH Agriculture, Forestry, and Fishing Program to evaluate the 1) relevance of its work to improvements in occupational safety and health and 2) the impact of research in reducing workplace illnesses and injuries. The assessment reveals that the program has made meaningful contributions to improving worker safety and health in these fields. To enhance the relevance and impact of its work and fulfill its mission, the NIOSH Agriculture, Forestry, and Fishing Program should provide national leadership, coordination of research, and activities to transfer findings, technologies, and information into practice. The program will also benefit from establishing strategic goals and implementing a comprehensive surveillance system in order to better identify and track worker populations at risk.
Book Synopsis Advances in Patient Safety by : Kerm Henriksen
Download or read book Advances in Patient Safety written by Kerm Henriksen and published by . This book was released on 2005 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Book Synopsis Food and Feed Safety Systems and Analysis by : Steven Ricke
Download or read book Food and Feed Safety Systems and Analysis written by Steven Ricke and published by Academic Press. This book was released on 2017-10-16 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt: Food and Feed Safety Systems and Analysis discusses the integration of food safety with recent research developments in food borne pathogens. The book covers food systems, food borne ecology, how to conduct research on food safety and food borne pathogens, and developing educational materials to train incoming professionals in the field. Topics include data analysis and cyber security for food safety systems, control of food borne pathogens and supply chain logistics. The book uniquely covers current food safety perspectives on integrating food systems concepts into pet food manufacturing, as well as data analyses aspects of food systems. - Explores cutting edge research about emerging issues associated with food safety - Includes new research on understanding foodborne Salmonella, Listeria and E. coli - Presents foodborne pathogens and whole genome sequencing applications - Provides concepts and issues related to pet and animal feed safety
Book Synopsis Science, Medicine, and Animals by : National Research Council
Download or read book Science, Medicine, and Animals written by National Research Council and published by National Academies Press. This book was released on 2006-02-19 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher's Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the goals of biomedical research and the real-world practice of the scientific method in general. Science, Medicine, and Animals and the Teacher's Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher's Guide was reviewed by members of the National Academies' Teacher Associates Network. Science, Medicine, and Animals is recommended by the National Science Teacher's Association NSTA Recommends.
Book Synopsis Water Safety, Security and Sustainability by : Ashok Vaseashta
Download or read book Water Safety, Security and Sustainability written by Ashok Vaseashta and published by Springer Nature. This book was released on 2021-07-14 with total page 725 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Present Knowledge in Food Safety by : Michael E. Knowles
Download or read book Present Knowledge in Food Safety written by Michael E. Knowles and published by Elsevier. This book was released on 2022-10-10 with total page 1188 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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)
Book Synopsis Foundations of Safety Science by : Sidney Dekker
Download or read book Foundations of Safety Science written by Sidney Dekker and published by Routledge. This book was released on 2019-04-09 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt: How are today’s ‘hearts and minds’ programs linked to a late-19th century definition of human factors as people’s moral and mental deficits? What do Heinrich’s ‘unsafe acts’ from the 1930’s have in common with the Swiss cheese model of the early 1990’s? Why was the reinvention of human factors in the 1940’s such an important event in the development of safety thinking? What makes many of our current systems so complex and impervious to Tayloristic safety interventions? ‘Foundations of Safety Science’ covers the origins of major schools of safety thinking, and traces the heritage and interlinkages of the ideas that make up safety science today. Features Offers a comprehensive overview of the theoretical foundations of safety science Provides balanced treatment of approaches since the early 20th century, showing interlinkages and cross-connections Includes an overview and key points at the beginning of each chapter and study questions at the end to support teaching use Uses an accessible style, using technical language where necessary Concentrates on the philosophical and historical traditions and assumptions that underlie all safety approaches
Author :Council for International Organizations of Medical Sciences (CIOMS) Publisher :Cioms ISBN 13 :9789290360827 Total Pages :0 pages Book Rating :4.3/5 (68 download)
Book Synopsis Practical Aspects of Signal Detection in Pharmacovigilance by : Council for International Organizations of Medical Sciences (CIOMS)
Download or read book Practical Aspects of Signal Detection in Pharmacovigilance written by Council for International Organizations of Medical Sciences (CIOMS) and published by Cioms. This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.
Book Synopsis From Safety to Safety Science by : Paul Swuste
Download or read book From Safety to Safety Science written by Paul Swuste and published by Routledge. This book was released on 2021-11-29 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: How do accidents and disasters occur? How has knowledge of accident processes evolved? A significant improvement in safety has occurred during the past century, with the number of accidents falling spectacularly within industry, aviation and road traffic. This progress has been gradual in the context of a changing society. The improvements are partly due to a better understanding of the accident processes that ultimately lead to damage. This book shows how contemporary crises instigated the development of safety knowledge and how the safety sciences pieced their theories together by research, by experience and by taking ideas from other domains. From Safety to Safety Science details 150 years of knowledge development in the safety sciences. The authors have rigorously extracted the essence of safety knowledge development from more than 2,500 articles to provide a unique overview and insight into the background and usability of safety theories, as well as modelling how they developed and how they are used today. Extensive appendices and references provide an additional dimension to support further scholarly work in this field. The book is divided into clear time periods to make it an accessible piece of science history that will be invaluable to both new and experienced safety researchers, to safety courses and education, and to learned practitioners.
Book Synopsis Occupational Safety and Hygiene VI by : Pedro M. Arezes
Download or read book Occupational Safety and Hygiene VI written by Pedro M. Arezes and published by CRC Press. This book was released on 2018-03-14 with total page 785 pages. Available in PDF, EPUB and Kindle. Book excerpt: Occupational Safety and Hygiene VI collects recent papers of selected authors from 21 countries in the domain of occupational safety and hygiene (OSH). The contributions cover a wide range of topics, including: - Occupational safety - Risk assessment - Safety management - Ergonomics - Management systems - Environmental ergonomics - Physical environment - Construction safety, and - Human factors Occupational Safety and Hygiene VI represents the state-of-the-art on the above mentioned domains, and is based on research carried out at universities and other research institutions. Some contributions focus more on practical case studies developed by OSH practitioners within their own companies. Hence, the book provides practical tools and approaches currently used by OHS practitioners in a global context.
Book Synopsis Emerging Demands for the Safety of Nuclear Power Operations by : Naosuke Itoigawa
Download or read book Emerging Demands for the Safety of Nuclear Power Operations written by Naosuke Itoigawa and published by CRC Press. This book was released on 2004-07-08 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technological and social aspects of industrial safety come under the scrutiny of scientists and engineers from an array of backgrounds. This is the third publication developed from a very fruitful, longstanding cooperation between the Institute of Social Research within the Institute of Nuclear Safety System in Japan, and the Research Center System. The book presents a cross-disciplinary, state-of-the-art look at the latest human factors developments in the industry, with wider applications for the entire industrial sector. Expert contributors explore issues in key areas.
Book Synopsis Safety Science Research by : Jean-Christophe Le Coze
Download or read book Safety Science Research written by Jean-Christophe Le Coze and published by CRC Press. This book was released on 2019-08-13 with total page 245 pages. Available in PDF, EPUB and Kindle. Book excerpt: Safety Science Research: Evolution, Challenges and New Directions provides a unique perspective into the latest developments of safety science by putting together, for the first time, a new generation of authors with some of the pioneers of the field. Forty years ago, research traditions were developed, including, among others, high-reliability organisations, cognitive system engineering or safety regulations. In a fast-changing world, the new generation introduces, in this book, new disciplinary insights, addresses contemporary empirical issues, develops new concepts and models while remaining critical of safety research practical ambitions. Their ideas are then reflected and discussed by some of the pioneers of safety science. Features Allows the reader to discover how contemporary safety issues are currently framed by a new generation of researchers, brought together for the first time Includes an introduction and guide to the development of safety science over the last four decades Features an extraordinary collection of expert contributors, including pioneers of safety research, reflecting the evolution of the discipline and offering insightful commentary on the current and future state of the field Serves as an invaluable reference and guide for safety professionals and students from any established disciplines such as sociology, engineering, psychology, political science or management as well as dedicated safety programmes Some figures in the eBook are in colour