Benefits Assessment

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Benefits Assessment

Author : J.D. Bentkover,V.T. Covello,J.L. Mumpower
Publisher : Springer Science & Business Media
Page : 245 pages
File Size : 40,7 Mb
Release : 2012-12-06
Category : Technology & Engineering
ISBN : 9789400945241

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Benefits Assessment by J.D. Bentkover,V.T. Covello,J.L. Mumpower Pdf

In recent years there has been substantial interest in benefits assessment methods, especially as these methods are used to assess health, safety, and environmental issues. At least part of this interest can be traced to Executive Order 12291, issued by President Ronald Reagan in 1981. This Executive Order requires Federal agencies to perform benefits assessments of pro posed major regulations and prohibits them from taking regulatory action unless potential benefits exceed potential costs to society. Heightened interest in benefits assessment methods has in tum given rise to greater recognition of the inherent difficulties in performing such assess ments. For example, many benefits that are intuitively felt to be most important are also among the most difficult to measure. It can be difficult to identify the full range of both benefits and costs. The choice of an appro priate discount rate for comparing benefits and costs over time is proble matic. Even when benefits are quantifiable in principle and agreement can be reached on their valuation, required d,ata may not be available. Thus considerable uncertainty is built into most benefit estimates, even when they are based on the best available data. In light of the complexities and difficulties associated with the perform ance of a benefits assessment, this book reviews the current state of theoretical and methodological knowledge in the field. The review is extensive in that it covers over fifty years of research, theoretical develop ment, and practice.

Benefits Assessment

Author : J.D. Bentkover,V.T. Covello,J.L. Mumpower
Publisher : Springer Science & Business Media
Page : 264 pages
File Size : 50,5 Mb
Release : 1986
Category : Business & Economics
ISBN : 9027720223

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Benefits Assessment by J.D. Bentkover,V.T. Covello,J.L. Mumpower Pdf

Research papers, evaluation, social security, welfare, health, safety, social environment, quality of life, model, statistical methods. - Bibliography, statistical tables.

Fungicide Benefits Assessment

Author : Anonim
Publisher : Unknown
Page : 28 pages
File Size : 52,8 Mb
Release : 1991
Category : Fungicides
ISBN : OSU:32435078076643

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Fungicide Benefits Assessment by Anonim Pdf

Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 150 pages
File Size : 53,5 Mb
Release : 2014-12-19
Category : Medical
ISBN : 9780309310031

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Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process itself that might limit the generalizability of results. As a result, regulatory reviewers are consistently required to draw conclusions about a drug's safety and efficacy from imperfect data. Efforts are underway within the drug development community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutical products, aimed at increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. Effectively communicating regulatory decisions necessarily includes explanation of the impact of uncertainty on decision making. On February 12 and May 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held public workshops to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions on February 12 were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products summarizes the presentation and discussion of both events. This report explores potential analytical and communication approaches and identifies key considerations on their development, evaluation, and incorporation into pharmaceutical benefit- risk assessment throughout the entire drug development lifecycle.

Assessment of the Benefits of Extending the Tropical Rainfall Measuring Mission

Author : National Research Council,Division on Earth and Life Studies,Board on Atmospheric Sciences and Climate,Committee on the Future of the Tropical Rainfall Measuring Mission
Publisher : National Academies Press
Page : 116 pages
File Size : 41,5 Mb
Release : 2006-09-22
Category : Science
ISBN : 9780309102827

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Assessment of the Benefits of Extending the Tropical Rainfall Measuring Mission by National Research Council,Division on Earth and Life Studies,Board on Atmospheric Sciences and Climate,Committee on the Future of the Tropical Rainfall Measuring Mission Pdf

Launched jointly in 1997 by the National Aeronautics and Space Administration (NASA) and the Japan Aerospace Exploration Agency (JAXA), the Tropical Rainfall Measuring Mission (TRMM) is a satellite mission that placed a unique suite of instruments, including the first precipitation radar, in space. These instruments are used to monitor and predict tropical cyclone tracks and intensity, estimate rainfall, and monitor climate variability (precipitation and sea surface temperature). TRMM has been collecting data for seven years; this data is used by the Joint Typhoon Warning Center, the National Center for Environmental Prediction, and the National Hurricane Center, among others worldwide. In July 2004, NASA announced that it would terminate TRMM in August 2004. At the request of the National Oceanic and Atmospheric Administration (NOAA), the White House, and the science community, NASA agreed to continue TRMM operations through the end of 2004. Meanwhile, NASA asked a National Research Council (NRC) committee to provide advice on the benefits of keeping TRMM in operation beyond 2004. After holding a workshop with a number of experts in the field, the committee found that TRMM will contribute significantly to operations and science if the mission is extended; and therefore, strongly recommends continued operation of TRMM with the caveat that cost and risk will need to be further examined before a final decision about the future of TRMM can be made.

Benefits Assessment

Author : J. D. Bentkover,V. T. Covello,J. L. Mumpower
Publisher : Unknown
Page : 256 pages
File Size : 41,5 Mb
Release : 2014-01-15
Category : Electronic
ISBN : 9400945256

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Benefits Assessment by J. D. Bentkover,V. T. Covello,J. L. Mumpower Pdf

Benefit-Risk Assessment of Medicines

Author : James Leong,Sam Salek,Stuart Walker
Publisher : Springer
Page : 317 pages
File Size : 54,6 Mb
Release : 2015-04-21
Category : Medical
ISBN : 9783319158051

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Benefit-Risk Assessment of Medicines by James Leong,Sam Salek,Stuart Walker Pdf

This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.

Benefit-Risk Assessment Methods in Medical Product Development

Author : Qi Jiang,Weili He
Publisher : CRC Press
Page : 296 pages
File Size : 45,9 Mb
Release : 2017-12-19
Category : Mathematics
ISBN : 9781482259377

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Benefit-Risk Assessment Methods in Medical Product Development by Qi Jiang,Weili He Pdf

Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations.

Understanding by Design

Author : Grant P. Wiggins,Jay McTighe
Publisher : ASCD
Page : 383 pages
File Size : 47,8 Mb
Release : 2005
Category : Education
ISBN : 9781416600350

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Understanding by Design by Grant P. Wiggins,Jay McTighe Pdf

What is understanding and how does it differ from knowledge? How can we determine the big ideas worth understanding? Why is understanding an important teaching goal, and how do we know when students have attained it? How can we create a rigorous and engaging curriculum that focuses on understanding and leads to improved student performance in today's high-stakes, standards-based environment? Authors Grant Wiggins and Jay McTighe answer these and many other questions in this second edition of Understanding by Design. Drawing on feedback from thousands of educators around the world who have used the UbD framework since its introduction in 1998, the authors have greatly revised and expanded their original work to guide educators across the K-16 spectrum in the design of curriculum, assessment, and instruction. With an improved UbD Template at its core, the book explains the rationale of backward design and explores in greater depth the meaning of such key ideas as essential questions and transfer tasks. Readers will learn why the familiar coverage- and activity-based approaches to curriculum design fall short, and how a focus on the six facets of understanding can enrich student learning. With an expanded array of practical strategies, tools, and examples from all subject areas, the book demonstrates how the research-based principles of Understanding by Design apply to district frameworks as well as to individual units of curriculum. Combining provocative ideas, thoughtful analysis, and tested approaches, this new edition of Understanding by Design offers teacher-designers a clear path to the creation of curriculum that ensures better learning and a more stimulating experience for students and teachers alike.

Potential Risks and Benefits of Gain-of-Function Research

Author : National Research Council,Institute of Medicine,Board on Health Sciences Policy,Policy and Global Affairs,Committee on Science, Technology, and Law,Division on Earth and Life Studies,Board on Life Sciences
Publisher : National Academies Press
Page : 140 pages
File Size : 42,9 Mb
Release : 2015-04-13
Category : Science
ISBN : 9780309367868

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Potential Risks and Benefits of Gain-of-Function Research by National Research Council,Institute of Medicine,Board on Health Sciences Policy,Policy and Global Affairs,Committee on Science, Technology, and Law,Division on Earth and Life Studies,Board on Life Sciences Pdf

On October 17, 2014, spurred by incidents at U.S. government laboratories that raised serious biosafety concerns, the United States government launched a one-year deliberative process to address the continuing controversy surrounding so-called "gain-of-function" (GOF) research on respiratory pathogens with pandemic potential. The gain of function controversy began in late 2011 with the question of whether to publish the results of two experiments involving H5N1 avian influenza and continued to focus on certain research with highly pathogenic avian influenza over the next three years. The heart of the U.S. process is an evaluation of the potential risks and benefits of certain types of GOF experiments with influenza, SARS, and MERS viruses that would inform the development and adoption of a new U.S. Government policy governing the funding and conduct of GOF research. Potential Risks and Benefits of Gain-of-Function Research is the summary of a two-day public symposia on GOF research. Convened in December 2014 by the Institute of Medicine and the National Research Council, the main focus of this event was to discuss principles important for, and key considerations in, the design of risk and benefit assessments of GOF research. Participants examined the underlying scientific and technical questions that are the source of current discussion and debate over GOF research involving pathogens with pandemic potential. This report is a record of the presentations and discussion of the meeting.