benefit risk assessment of medicines the development and application of a universal framework for decision making and effective communication

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Benefit Risk Assessment Of Medicines

Author : James Leong
ISBN : 9783319158051
Genre : Medical
File Size : 79. 63 MB
Format : PDF
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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
ISBN : 9781315355016
Genre : Mathematics
File Size : 51. 93 MB
Format : PDF, Kindle
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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.

Post Authorization Safety Studies Of Medicinal Products

Author : Ayad K. Ali
ISBN : 9780128092088
Genre : Medical
File Size : 84. 78 MB
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Post-Authorization Safety Studies of Medicinal Products: The PASS Book bridges the gap in the literature by providing a complete look at post-authorization safety studies and important pharmacoepidemiology and pharmacovigilance aspects. It covers various types and limitations of active surveillance programs, including the use of large databases and disparate data sources for rapid signal detection, as well as novel and advanced design and analysis approaches for causal interference from observational data. This book serves as an important reference for pharmacovigilance scientists and pharmacoepidemiologists who are searching for the appropriate study design to answer safety research questions. Readers will be able to effectively and efficiently design and interpret findings from post-authorization safety studies with the goal of improving the benefit-risk balance of a drug in order to optimize patient safety. Discusses all types of observational studies in post-marketing drug safety assessment, from spontaneous reporting systems, to pragmatic trials, with examples from real-world settings Presents various types of post-authorization safety studies Offers solutions to the common challenges in the design and conduct of these studies Highlights active surveillance programs, including common data models for rapid signal detection of drug safety issues

Benefit Risk Appraisal Of Medicines

Author : Filip Mussen
ISBN : 9780470748121
Genre : Medical
File Size : 74. 60 MB
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Benefit-risk assessment is at the centre of the approval process for every new medicine. The ability to assess the risks of a new medicine accurately and to balance these against the benefits the medicine could bring is critical for every regulatory authority and pharmaceutical company. Despite this there are very few tried and tested evaluative models currently available. The authors of this book have developed a new, pioneering tool for the assessment of benefits and risks for new medicines in development. This model utilises a multi-criteria decision analysis which involves selecting, scoring and weighting key benefit and risk attributes and leads to an overall appraisal of benefits and risks of medicines. Benefit-Risk Appraisal of Medicines establishes the background and criteria required to assess benefit and risk in general and reviews the current practices by regulatory authorities and the pharmaceutical industry, including those models currently available. It outlines the development and evaluation of the authors’ new model and analyses the implications of its implementation. Describes an innovative, systematic model which leads to transparent and responsible benefit-risk decision making Contributes important ideas to the debate on benefit-risk appraisal Provides a future framework for benefit-risk appraisal of medicines Benefit-Risk Appraisal of Medicines covers the entire process from the discovery of new medicines to their marketing and is ideal for all those who work in the pharmaceutical industry and regulatory authorities,, as well as post-graduate students of pharmaceutical medicine and clinical pharmacology.

Communicating Risks And Benefits

Author : Baruch Fischhoff
ISBN : 0160901790
Genre : Health & Fitness
File Size : 51. 50 MB
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Effective risk communication is essential to the well-being of any organization and those people who depend on it. Ineffective communication can cost lives, money and reputations. Communicating Risks and Benefits: An Evidence-Based User’s Guide provides the scientific foundations for effective communications. The book authoritatively summarizes the relevant research, draws out its implications for communication design, and provides practical ways to evaluate and improve communications for any decision involving risks and benefits. Topics include the communication of quantitative information and warnings, the roles of emotion and the news media, the effects of age and literacy, and tests of how well communications meet the organization’s goals. The guide will help users in any organization, with any budget, to make the science of their communications as sound as the science that they are communicating.

The Tolerability Of Risk

Author : Frederic Bouder
ISBN : 9781136551819
Genre : Business & Economics
File Size : 49. 63 MB
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There is an increasing dissatisfaction about how risk is regulated, leading to vivid debates about the use of 'risk assessment' and 'precaution'. As a result, academics, government officials and industry leaders are calling for new approaches and fresh ideas. This book provides a historical and topical perspective on the alternative concept of 'Tolerability of Risk' and its concrete regulatory applications. In the UK, Tolerability of Risk has been developed into a sophisticated framework, particularly within the health and safety sectors. It is expected to guide decision-makers when applying their legal obligation of keeping risks as low as practically reasonable. Could Tolerability of Risk become a wider source of inspiration across the full scope of risk analysis and management? Written by leading academics and risk practitioners from industry and government, The Tolerability of Risk presents a summary of theoretical perspectives on risk approaches, providing a detailed elicitation of the methods and approaches used to build the Tolerability of Risk framework and examining the prospect of universal application of that framework. From nuclear power to environmental pollution, climate change and drug testing, the Tolerability of Risk framework may offer a workable, pragmatic solution for balancing risks against the costs involved in controlling them, as well as developing the institutional capacity to make effective decisions in all jurisdictions worldwide.

International Cooperation Convergence And Harmonization Of Pharmaceutical Regulations

Author : Pierre-Louis Lezotre
ISBN : 9780128005699
Genre : Medical
File Size : 44. 46 MB
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International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective provides the current status of the complex and broad phenomenon of cooperation, convergence and harmonization in the pharmaceutical sector (Part I), thoroughly evaluates its added value and its critical parameters and influencing factors (Part II) in order to recommend actions and measures to support the next steps for cooperation, convergence and harmonization (Part III). All of these recommendations in the book support the establishment of a better coordinated global pharmaceutical system which represents the best realistic alternative to fulfill the objective to establish a global coalition of regulators and to respond to an increased demand to further cooperation in the pharmaceutical sector. This proposed framework, which leverages all of the ongoing positive cooperation initiatives and uses as foundations all of the numerous harmonization projects developed over the years, presents advantages for all stakeholders and would definitively have significant added value to the promotion and protection of global public health. The status of all major worldwide harmonization and cooperation initiatives (at bilateral, regional, and global levels) The value of cooperation in the pharmaceutical sector and the driving factors behind harmonization The proposition of a structure for the global pharmaceutical system and timely recommendations for enhancing international cooperation, as well as further discussion and policy changes in this area

Health Care Transition

Author : Albert C. Hergenroeder
ISBN : 9783319728681
Genre : Medical
File Size : 53. 48 MB
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This comprehensive book thoroughly addresses all aspects of health care transition of adolescents and young adults with chronic illness or disability; and includes the framework, tools and case-based examples needed to develop and evaluate a Health Care Transition (HCT) planning program that can be implemented regardless of a patient’s disease or disability. Health Care Transition: Building a Program for Adolescents and Young Adults with Chronic Illness and Disability is a uniquely inclusive resource, incorporating youth/young adult, caregiver, and pediatric and adult provider voices and perspectives. Part I of the book opens by defining Health Care Transition, describing the urgent need for comprehensive transition planning, barriers to HCT and then offering a framework for developing and evaluating health care transition programs. Part II focuses on the anatomic and neuro-chemical changes that occur in the brain during adolescence and young adulthood, and how they affect function and behavior. Part III covers the perspectives of important participants in the HCT transition process – youth and young adults, caregivers, and both pediatric and adult providers. Each chapter in Part IV addresses a unique aspect of developing HCT programs. Part V explores various examples of successful transition from the perspective of five key participants in the transition process - patients, caregivers, pediatric providers, adult providers and third party payers. Related financial matters are covered in part VI, while Part VII explores special issues such as HCT and the medical home, international perspectives, and potential legal issues. Models of HCT programs are presented in Part VIII, utilizing an example case study. Representing perspectives from over 75 authors and more than 100 medical centers in North America and Europe, Health Care Transition: Building a Program for Adolescents and Young Adults with Chronic Illness and Disability is an ideal resource for any clinician, policy maker, caregiver, or hospitalist working with youth in transition.

Drug Benefits And Risks

Author : C.J. van Boxtel
ISBN : 9781607503453
Genre : Medical
File Size : 75. 20 MB
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This updated and revised 2nd edition of Drug Benefits and Risks is an inclusive reference exploring the scientific basis and practice of drug therapy. The key concept is to look at the balance between the benefits and risks of drugs, but in this context also highlighting the social impact which drugs have in modern societies. Taking an evidence-based approach to the problem, the practice of clinical pharmacology and pharmacotherapy in the developing as well as the developed world is examined. For this purpose the book covers general clinical pharmacology, pharmacology of various drug groups and the treatments specific to various diseases; the book gives guidance on how doctors should act so that drugs can be used effectively and safely; and it encourages the rational use of drugs in society. This publication brings together a large amount of excellent content that will be invaluable for anyone working within, or associated with, the field of clinical pharmacology and pharmacotherapy - undergraduates, postgraduates, regulatory authorities and the pharmaceutical industry.

Schools

Author : United Nations Office on Drugs and Crime
ISBN : 9211481910
Genre : Psychology
File Size : 71. 3 MB
Format : PDF
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"This publication does not offer a pre-packaged programme of education for drug abuse prevention that can be picked up and implemented. It is rather an attempt to provide a conceptual basis upon which teachers, policy makers and school administrators can make decisions about school based drug prevention programmes in order to achieve greater success in education terms" -- p. 6.

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