Benefit-Risk Assessment of Medicines - The Development and Application of a Universal Framework for Decision-Making and Effective Communication (Hardcover, 2015 ed.)

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.

General

Imprint:	Adis International
Country of origin:	Switzerland
Release date:	May 2015
First published:	2015
Authors:	James Leong • Sam Salek • Stuart Walker
Dimensions:	235 x 155 x 25mm (L x W x T)
Format:	Hardcover
Pages:	317
Edition:	2015 ed.
ISBN-13:	978-3-319-15804-4
Categories:	Books > Medicine > Other branches of medicine > Pharmacology > General Books > Medicine > General issues > Public health & preventive medicine > Personal & public health > General
LSN:	3-319-15804-X
Barcode:	9783319158044

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