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Softcover - 9783319367675
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Beschreibung
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.The Development and Application of a Universal Framework for Decision-Making and Effective Communication
The Development and Application of a Universal Framework for Decision-Making and Effective Communication
Details
| Verlag | Springer International Publishing |
| Ersterscheinung | 05. Mai 2015 |
| Maße | 23.5 cm x 15.5 cm |
| Gewicht | 664 Gramm |
| Format | Hardcover |
| ISBN-13 | 9783319158044 |
| Seiten | 317 |
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