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Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309110122 Category : Medical Languages : en Pages : 150
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 In addition to the slowing rate of drug development and approval, recent years have seen a number of drugs withdrawn from the market for safety reasons. According to the Government Accountability Office (GAO), 10 drugs were withdrawn because of safety concerns between 2000 and March 2006 (GAO, 2006).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
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: Jean-Christophe Le Coze Publisher: CRC Press ISBN: 1351190229 Category : Technology & Engineering Languages : en Pages : 326
Book Description
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
Author: Steven C Ricke Publisher: Academic Press ISBN: 0128004045 Category : Technology & Engineering Languages : en Pages : 464
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: Albert Kuhlmann Publisher: Springer Science & Business Media ISBN: 1461385962 Category : Business & Economics Languages : en Pages : 465
Book Description
For many years "safety technology" has constituted the essential instrument for the prevention of accidents as a direct result of handling new technology. Its awareness of the interactions prevalent in natural science causes safety technology to act on the basis of actual accidents, and it Ulilizes to their fullest extent any means provided by the engineering sciences. Man proceeds in a general direction towards preselVation and improvement, thus working towards the optimization of the technical design. However. a new set of basic problems presented itself the moment new large-scale technologies were introduced into the areas of processing, energy, and traffic, thereby creating a considerable amount of ad ditional danger potential. This also signified the end of an era when safety technology could be practiced chiefly on the basis of accident statistics. For ethical reasons it became necessary that a credible prognosis as to the type and effect of accidents took the place, or at least supplemented, the hitherto practiced purely reactive methods. The realization that the available means of safety technology were no longer sufficient in a highly technologized environment spurred the demand for entirely new concepts which would eventually lead to a higher degree of safety. A decisive step had to be taken away from a purely technical approach and fOwards and all-encompassing look at accident systems, because man had become aware of the fact that accidents will always be a part of the interaction between man, technology, and environment.
Author: Tung-Sang Ng Publisher: Pergamon ISBN: Category : Computers Languages : en Pages : 248
Book Description
Paperback. Increasingly, over the last few years, intelligent controllers have been incorporated into control systems. Presently, the numbers and types of intelligent controllers that contain variations of fuzzy logic, neural network, genetic algorithms or some other forms of knowledge based reasoning technology are dramatically rising. However, considering the stability of the system, when such controllers are included it is difficult to analyse and predict system behaviour under unexpected conditions. Leading researchers and industrial practitioners were able to discuss and evaluate current development and future research directions at the first IFAC International Workshop on safety, reliability and applications on emerging intelligent control technology. This publication contains the papers, covering a wide range of topics, presented at the workshop.
Author: Eugene Williams Publisher: Nova Science Publishers ISBN: 9781536107463 Category : Medical care Languages : en Pages : 0
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
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: Michael K. Pugsley Publisher: Springer ISBN: 366246943X Category : Medical Languages : en Pages : 481
Book Description
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: Institute of Medicine Publisher: National Academies Press ISBN: 0309072808 Category : Medical Languages : en Pages : 360
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: National Research Council Publisher: National Academies Press ISBN: 0309300940 Category : Science Languages : en Pages : 128
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
Author: Institute of Medicine
Author: Jean-Christophe Le Coze
Author: Steven C Ricke
Author: Albert Kuhlmann
Author: Tung-Sang Ng
Author: Eugene Williams
Author: Rani Lill Anjum
Author: Michael K. Pugsley
Author: Institute of Medicine
Author: National Research Council