Description: Benefit-risk Assessment of Medicines : The Development and Application of a Universal Framework for Decision-making and Effective Communication, Paperback by Leong, James; Salek, Sam; Walker, Stuart, ISBN 3319367676, ISBN-13 9783319367675, Brand New, Free shipping in the US 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.
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Book Title: Benefit-risk Assessment of Medicines : The Development and Applic
Number of Pages: Xiii, 317 Pages
Publication Name: Benefit-Risk Assessment of Medicines : The Development and Application of a Universal Framework for Decision-Making and Effective Communication
Language: English
Publisher: Springer International Publishing A&G
Publication Year: 2016
Item Height: 0.7 in
Subject: Allied Health Services / General, Pharmacology
Type: Textbook
Item Weight: 177.7 Oz
Item Length: 9.2 in
Subject Area: Medical
Author: Sam Salek, Stuart Walker, James Leong
Item Width: 6.1 in
Format: Trade Paperback
