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 : 74. 70 MB
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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 : 34. 72 MB
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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. 14 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 : 72. 41 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.

Pharmaceutical Regulatory Environment

Author : Reem K. Al-Essa
ISBN : 9783319175904
Genre : Medical
File Size : 23. 4 MB
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This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients’ access to new medicines. The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.

The Tolerability Of Risk

Author : Frederic Bouder
ISBN : 9781849773324
Genre : Business & Economics
File Size : 63. 69 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.

Unsere Gemeinsame Zukunft

Author : Volker Hauff
ISBN : 3923166168
Genre :
File Size : 85. 22 MB
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Laudato Si

Author : Franziskus (Papst),
ISBN : 9783451807367
Genre : Religion
File Size : 46. 47 MB
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Mit großer Spannung wurde sie erwartet, auch von Nicht-Katholiken: Die Umwelt-Enzyklika von Papst Franziskus nimmt die heute entscheidenden Themen in den Blick; es geht um die geht um soziale, ökologische und politische Zusammenhänge. Wohl selten war ein päpstliches Schreiben so aktuell und brisant und vor allem relevant für alle Gesellschaftsschichten und Menschen weltweit. Mit "Laudato si" beweist Franziskus, dass die Kirche nach wie vor eine unverzichtbare Stimme im Diskurs zur Gestaltung der modernen Welt ist. Wer verstehen will, wie Papst und Kirche die großen Herausforderungen unserer Zeit bestehen wollen, kommt an diesem Werk nicht vorbei. Ein Muss für jeden, der an den drängenden Fragen unserer Zeit interessiert ist.

Dissertation Abstracts International

Author :
ISBN : STANFORD:36105121673201
Genre : Science
File Size : 75. 71 MB
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Safety And Health At Work

Author :
ISBN : CORNELL:31924092415573
Genre : Industrial hygiene
File Size : 57. 51 MB
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