Benefit-Risk Assessment of Medicines
The Development and Application of a Universal Framework for Decision-Making and Effective Communication
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22 184 Ft
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Product details:
- Edition number 2015
- Publisher Springer International Publishing
- Date of Publication 5 May 2015
- Number of Volumes 1 pieces, Book
- ISBN 9783319158044
- Binding Hardback
- No. of pages317 pages
- Size 235x155 mm
- Weight 799 g
- Language English
- Illustrations XIII, 317 p. 163 illus., 138 illus. in color. Illustrations, black & white 0
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Long description:
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. MoreTable of Contents:
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.
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