Benefit-Risk Assessment of Medicines: The Development and Application of a Universal Framework for Decision-Making and Effective Communication 2015th Edition

by James Leong (Author), Sam Salek (Author), Stuart Walker (Author)

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ISBN-13: 978-3319158044

ISBN-10: 331915804X

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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.

Benefit-Risk Assessment of Medicines: The Development and Application of a Universal Framework for Decision-Making and Effective Communication

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Product Details

Hardcover: 317 pages
Publisher: Adis; 2015 edition (April 22, 2015)
Language: English
ISBN-10: 331915804X
ISBN-13: 978-3319158044
Product Dimensions: 6.1 x 0.8 x 9.2 inches
Shipping Weight: 1.4 pounds (View shipping rates and policies)
Average Customer Review: Be the first to review this item
Amazon Best Sellers Rank: #3,651,322 in Books (See Top 100 in Books)
- #3063 in Books > Textbooks > Medicine & Health Sciences > Medicine > Basic Sciences > Pharmacology
- #3081 in Books > Textbooks > Medicine & Health Sciences > Administration & Policy > Public Health
- #6010 in Books > Medical Books > Administration & Medicine Economics > Public Health

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