Adis
Benefit-Risk Assessment of Medicines: The Development and Application of a Universal Framework for Decision-Making and Effective Communication
Product Code:
9783319158044
ISBN13:
9783319158044
Condition:
New
$61.47
Benefit-Risk Assessment of Medicines: The Development and Application of a Universal Framework for Decision-Making and Effective Communication
$61.47
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.| Author: James Leong |
| Publisher: Adis |
| Publication Date: May 05, 2015 |
| Number of Pages: 317 pages |
| Binding: Hardback or Cased Book |
| ISBN-10: 331915804X |
| ISBN-13: 9783319158044 |
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