Benefit-Risk Assessment of Medicines : The Development and Application of a Universal Framework for Decision-Making and Effective Communication
2015
Online
E-Book
Zugriff:
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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Benefit-Risk Assessment of Medicines : The Development and Application of a Universal Framework for Decision-Making and Effective Communication
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Autor/in / Beteiligte Person: | Leong, James ; Salek, Sam ; Walker, Stuart |
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Veröffentlichung: | 2015 |
Medientyp: | E-Book |
ISBN: | 978-3-319-15804-4 (print) ; 978-3-319-15805-1 (electronic) |
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