Download the fantastic book titled Benefit Risk Assessment of Medicines written by James Leong, available in its entirety in both PDF and EPUB formats for online reading. This page includes a concise summary, a preview of the book cover, and detailed information about "Benefit Risk Assessment of Medicines", which was released on 21 April 2015. We suggest perusing the summary before initiating your download. This book is a top selection for enthusiasts of the Medical genre.
Summary of Benefit Risk Assessment of Medicines by James Leong PDF
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 About Benefit Risk Assessment of Medicines PDF
- Author : James Leong
- Publisher : Springer
- Genre : Medical
- Total Pages : 317 pages
- ISBN : 3319158058
- Release Date : 21 April 2015
- PDF File Size : 13,8 Mb
- Language : English
- Rating : 4/5 from 21 reviews
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