| 期刊全稱(chēng) | Benefit-Risk Assessment of Medicines | | 期刊簡(jiǎn)稱(chēng) | The Development and | | 影響因子2023 | James Leong,Sam Salek,Stuart Walker | | 視頻video | http://file.papertrans.cn/184/183420/183420.mp4 | | 發(fā)行地址 | Examines current approaches for the benefit-risk assessment of medicines and the acceptability of a “universal framework” by regulatory agencies and pharmaceutical companies.Presents the development a | | 圖書(shū)封面 |  | | 影響因子 | .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 globall | | Pindex | Book 2015 |
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