Benefit-Risk Assessment of Medicines The Development and Application of a Universal Framework for Decision-Making and Effective Communication /
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 benefi...
| Published in: | Springer eBooks |
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| Main Authors: | , , |
| Corporate Author: | |
| Format: | eBook |
| Language: | English |
| Published: |
Cham :
Springer International Publishing : Imprint: Adis,
2015.
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| Subjects: | |
| Online Access: | http://dx.doi.org/10.1007/978-3-319-15805-1 Перейти в каталог НБ ТГУ |
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| 100 | 1 | |a Leong, James. |e author. |9 465841 | |
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| 505 | 0 | |a Prologue -- Preface -- Overview -- Approaches to utilising decision-making framework -- Benefit-risk assessment of medicines by pharmaceutical companies and regulatory authorities -- Development of a universal benefit-risk framework and template -- Implementation of the benefit-risk assessment template by mature agencies -- Implementation of the benefit- risk summary template by a maturing agency: A case study -- Communicating benefit-risk decisions by US FDA, EMA, TGA and Health Canada -- Conclusions and future directions -- References. | |
| 520 | |a 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. | ||
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| 700 | 1 | |a Salek, Sam. |e author. |9 465842 | |
| 700 | 1 | |a Walker, Stuart. |e author. |9 465843 | |
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