| Benefit-Risk Assessment of Medicines: The Development and Application of a Universal Framework for Decision-Making and Effective Communication Softcover Repri Edition Contributor(s): Leong, James (Author), Salek, Sam (Author), Walker, Stuart (Author) |
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ISBN: 3319367676 ISBN-13: 9783319367675 Publisher: Adis OUR PRICE: $52.24 Product Type: Paperback - Other Formats Published: October 2016 |
| Additional Information |
| BISAC Categories: - Medical | Pharmacology - Medical | Public Health - Social Science | Anthropology - Cultural & Social |
| Dewey: 306 |
| Physical Information: 0.69" H x 6.14" W x 9.21" (1.03 lbs) 317 pages |
| Descriptions, Reviews, Etc. |
| Publisher 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. |