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Benefit-Risk Assessment of Medicines: The Development and Application of a Universal Framework for Decision-Making and Effective Communication (in English)
Sam Salek
(Author)
·
Stuart Walker
(Author)
·
James Leong
(Author)
·
Adis
· Paperback
Benefit-Risk Assessment of Medicines: The Development and Application of a Universal Framework for Decision-Making and Effective Communication (in English) - Leong, James ; Salek, Sam ; Walker, Stuart
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Synopsis "Benefit-Risk Assessment of Medicines: The Development and Application of a Universal Framework for Decision-Making and Effective Communication (in English)"
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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All books in our catalog are Original.
The book is written in English.
The binding of this edition is Paperback.
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