Benefit Risk Assessment of Medicines is popular PDF and ePub book, written by James Leong in 2015-04-21, it is a fantastic choice for those who relish reading online the Medical genre. Let's immerse ourselves in this engaging Medical book by exploring the summary and details provided below. Remember, Benefit Risk Assessment of Medicines can be Read Online from any device for your convenience.
Benefit Risk Assessment of Medicines Book PDF Summary
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.
Detail Book of Benefit Risk Assessment of Medicines PDF
- Author : James Leong
- Release : 21 April 2015
- Publisher : Springer
- ISBN : 9783319158051
- Genre : Medical
- Total Page : 326 pages
- Language : English
- PDF File Size : 17,5 Mb
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