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Risk Benefit Analysis
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Book Synopsis The Cambridge Handbook of Health Research Regulation by : Graeme Laurie
Download or read book The Cambridge Handbook of Health Research Regulation written by Graeme Laurie and published by . This book was released on 2021-06-09 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.
Book Synopsis Benefit-Risk Assessment of Medicines by : James Leong
Download or read book Benefit-Risk Assessment of Medicines written by James Leong and published by Springer. This book was released on 2015-04-21 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Potential Risks and Benefits of Gain-of-Function Research by : National Research Council
Download or read book Potential Risks and Benefits of Gain-of-Function Research written by National Research Council and published by National Academies Press. This book was released on 2015-04-13 with total page 131 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Risk-benefit Analysis by : Richard Wilson
Download or read book Risk-benefit Analysis written by Richard Wilson and published by . This book was released on 2001 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the centuries, mankind has slowly reduced the risks and hazards that even as recently as a century ago kept life expectancy to a mere 45 years. Our average lifespan has improved to 77 years by remarkable progress in public health and safety. But with this improvement has come a demand for greater efforts to improve both life expectancy and the quality of life. The first edition of this book, published in 1982, was a pioneer in the development of logical, yet simple, analytic tools for discussion of the risks which we all face. This new edition, revised, expanded, and illustrated in detail, should be of value both to professionals in the field and to those who wish to understand these vital issues.
Book Synopsis Cost-Benefit Analysis of Environmental Health Interventions by : Carla Guerriero
Download or read book Cost-Benefit Analysis of Environmental Health Interventions written by Carla Guerriero and published by Academic Press. This book was released on 2019-11-29 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cost-benefit Analysis of Environmental Health Interventions clearly articulates the core principles and fundamental methodologies underpinning the modern economic assessment of environmental intervention on human health. Taking a practical approach, the book provides a step-by-step approach to assigning a monetary value to the health benefits and disbenefits arising from interventions, using environmental information and epidemiological evidence. It summarizes environmental risk factors and explores how to interpret and understand epidemiological data using concentration-response, exposure-response or dose-response techniques, explaining the environmental interventions available for each environmental risk factor. It evaluates in detail two of the most challenging stages of Cost-Benefit Analysis in 'discounting' and 'accounting for uncertainty'. Further chapters describe how to analyze and critique results, evaluate potential alternatives to Cost-Benefit Analysis, and on how to engage with stakeholders to communicate the results of Cost-Benefit Analysis. The book includes a detailed case study how to conduct a Cost-Benefit Analysis. It is supported by an online website providing solution files and detailing the design of models using Excel. - Provides a clear understanding of the core theory of cost-benefit analysis in environmental health interventions - Provides practical guidance using real-world case studies to motivate and expand understanding - Describes the challenging 'discounting' and 'accounting for uncertainty' problems at chapter length - Supported by a practical case study, online solution files, and a practical guide to the design of CBA models using Excel
Book Synopsis Benefit-Risk Assessment in Pharmaceutical Research and Development by : Andreas Sashegyi
Download or read book Benefit-Risk Assessment in Pharmaceutical Research and Development written by Andreas Sashegyi and published by CRC Press. This book was released on 2013-11-27 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development and commercialization. Helping to alleviate this knowledge gap, Benefit-Risk Assessment in Pharmaceutical Research and Development provides a succinct overview of the key considerations rele
Book Synopsis Pharmacoepidemiology by : Brian L. Strom
Download or read book Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2019-12-16 with total page 1220 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dieses Lehrbuch, ein wegweisender Klassiker, bietet in der 6. Auflage noch mehr Inhalte für Leser, die aktuelle Informationen zur Pharmakoepidemiologie benötigen. Die vorliegende Auflage wurde vollständig überarbeitet und aktualisiert. Sie bietet einen Überblick über sämtliche Facetten des Fachgebiets, aus Sicht von Lehre und Forschung, aus Sicht der Industrie und von Regulierungsbehörden. Datenquellen, Anwendungen und Methodiken werden verständlich erläutert.
Book Synopsis The Benefit/Risk Ratio by : Hans C. Korting
Download or read book The Benefit/Risk Ratio written by Hans C. Korting and published by CRC Press. This book was released on 1998-07-24 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of drugs as remedies for various types of diseases has a long tradition; however, it has only been recently recognized that the value of any given compound must be evaluated in light of its benefit to risk ratio. When prescribing drugs, physicians must look at the big picture of the drug's benefits in relation to its side effects and possib
Author :Council for International Organizations of Medical Sciences (CIOMS) Publisher :World Health Organization ISBN 13 :9789290360889 Total Pages :0 pages Book Rating :4.3/5 (68 download)
Book Synopsis International Ethical Guidelines for Health-Related Research Involving Humans by : Council for International Organizations of Medical Sciences (CIOMS)
Download or read book International Ethical Guidelines for Health-Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.
Book Synopsis Decision Science and Social Risk Management by : M.W Merkhofer
Download or read book Decision Science and Social Risk Management written by M.W Merkhofer and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: Economists, decision analysts, management scientists, and others have long argued that government should take a more scientific approach to decision making. Pointing to various theories for prescribing and rational izing choices, they have maintained that social goals could be achieved more effectively and at lower costs if government decisions were routinely subjected to analysis. Now, government policy makers are putting decision science to the test. Recent government actions encourage and in some cases require government decisions to be evaluated using formally defined principles 01' rationality. Will decision science pass tbis test? The answer depends on whether analysts can quickly and successfully translate their theories into practical approaches and whether these approaches promote the solution of the complex, highly uncertain, and politically sensitive problems that are of greatest concern to government decision makers. The future of decision science, perhaps even the nation's well-being, depends on the outcome. A major difficulty for the analysts who are being called upon by government to apply decision-aiding approaches is that decision science has not yet evolved a universally accepted methodology for analyzing social decisions involving risk. Numerous approaches have been proposed, including variations of cost-benefit analysis, decision analysis, and applied social welfare theory. Each of these, however, has its limitations and deficiencies and none has a proven track record for application to govern ment decisions involving risk. Cost-benefit approaches have been exten sively applied by the government, but most applications have been for decisions that were largely risk-free.
Book Synopsis Well-Being and Fair Distribution by : Matthew Adler
Download or read book Well-Being and Fair Distribution written by Matthew Adler and published by . This book was released on 2012 with total page 656 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive philosophically grounded argument for the use of social welfare functions as a framework for governmental policy analysis.
Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine
Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
Book Synopsis Research Ethics in Africa by : Mariana Kruger
Download or read book Research Ethics in Africa written by Mariana Kruger and published by AFRICAN SUN MeDIA. This book was released on 2014-06-01 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this book is to provide research ethics committee members with a resource that focuses on research ethics issues in Africa. The authors are currently active in various aspects of research ethics in Africa and the majority have been trained in the past by either the Fogarty International Center or Europe and Developing Countries Clinical Trial Partnership (EDCTP) sponsored bioethics training programmes .
Book Synopsis Science and Decisions by : National Research Council
Download or read book Science and Decisions written by National Research Council and published by National Academies Press. This book was released on 2009-03-24 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk assessment has become a dominant public policy tool for making choices, based on limited resources, to protect public health and the environment. It has been instrumental to the mission of the U.S. Environmental Protection Agency (EPA) as well as other federal agencies in evaluating public health concerns, informing regulatory and technological decisions, prioritizing research needs and funding, and in developing approaches for cost-benefit analysis. However, risk assessment is at a crossroads. Despite advances in the field, risk assessment faces a number of significant challenges including lengthy delays in making complex decisions; lack of data leading to significant uncertainty in risk assessments; and many chemicals in the marketplace that have not been evaluated and emerging agents requiring assessment. Science and Decisions makes practical scientific and technical recommendations to address these challenges. This book is a complement to the widely used 1983 National Academies book, Risk Assessment in the Federal Government (also known as the Red Book). The earlier book established a framework for the concepts and conduct of risk assessment that has been adopted by numerous expert committees, regulatory agencies, and public health institutions. The new book embeds these concepts within a broader framework for risk-based decision-making. Together, these are essential references for those working in the regulatory and public health fields.
Book Synopsis Introduction to Cost–Benefit Analysis by : Ginés de Rus
Download or read book Introduction to Cost–Benefit Analysis written by Ginés de Rus and published by Edward Elgar Publishing. This book was released on 2021-03-26 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: This thoroughly updated second edition incorporates key ideas and discussions on issues such as wider economic impacts, the treatment of risk, and the importance of institutional arrangements in ensuring the correct use of technique. Ginés de Rus considers whether public decisions, such as investing in high-speed rail links, privatizing a public enterprise or protecting a natural area, may improve social welfare.
Book Synopsis Cost-Benefit Analysis for Project Appraisal by : Per-Olov Johansson
Download or read book Cost-Benefit Analysis for Project Appraisal written by Per-Olov Johansson and published by Cambridge University Press. This book was released on 2016 with total page 251 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book uses modern economic tools to obtain general equilibrium cost-benefit rules. It not only presents evaluation rules for small projects but also shows how to evaluate large projects as well as mega projects (such as high speed rails and channel tunnels). This is an excellent toolkit for graduate students and policymakers.
Book Synopsis Benefit-Cost Analysis by : Harry F. Campbell
Download or read book Benefit-Cost Analysis written by Harry F. Campbell and published by Cambridge University Press. This book was released on 2003-05-27 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: Throughout the text of this introduction to benefit cost analysis, emphasis is on applications, and a worked case study is progressively undertaken as an illustration of the analytical principles in operation. The first part covers basic theory and procedures. Part Two advances to material on internationally tradeable goods and projects that affect market prices, and part Three introduces special topics such as the treatment of risk and uncertainty, income distributional effects and the valuation of non-marketed goods. Instructors' resource web site: http://www.uq.edu.au/economics/bca
