Benefit-Risk Assessment of Medicines : The Development and Application of a Universal Framework for Decision-Making and Effective Communication Hardback
by James Leong, Sam Salek, Stuart Walker
Hardback
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.
Information
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Available to Order - This title is available to order, with delivery expected within 2 weeks
- Format:Hardback
- Pages:317 pages, 138 Illustrations, color; 25 Illustrations, black and white; XIII, 317 p. 163 illus., 138
- Publisher:Springer International Publishing AG
- Publication Date:05/05/2015
- Category:
- ISBN:9783319158044
Other Formats
- PDF from £38.24
- Paperback / softback from £45.25
Information
-
Available to Order - This title is available to order, with delivery expected within 2 weeks
- Format:Hardback
- Pages:317 pages, 138 Illustrations, color; 25 Illustrations, black and white; XIII, 317 p. 163 illus., 138
- Publisher:Springer International Publishing AG
- Publication Date:05/05/2015
- Category:
- ISBN:9783319158044
