Benefit-Risk Assessment of Medicines The Development and Application of a Universal Framework for Decision-Making and Effective Communication

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Synopsis

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.

Book details

Edition:
2015
Author:
James Leong, Sam Salek, Stuart Walker
ISBN:
9783319158051
Related ISBNs:
9783319158044
Publisher:
Springer International Publishing
Pages:
N/A
Reading age:
Not specified
Includes images:
Yes
Date of addition:
2019-09-07
Usage restrictions:
Copyright
Copyright date:
2015
Copyright by:
Springer International Publishing, Cham 
Adult content:
No
Language:
English
Categories:
Medicine, Nonfiction