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Benefit-Risk Assessment of Medicines

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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.

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Detail Information

Series Title

-

Call Number

571.49

Publisher

Cham : ., 2015

Collation

XXIII, 582

Language

English

ISBN/ISSN

978-3-319-15805-1

Classification

571.49

Content Type

text

Media Type

computer

Carrier Type

online resource

Edition

-

Subject(s)

Drug

Specific Detail Info

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Statement of Responsibility

James Leong, Sam Salek, Stuart Walker

Other Information

Cataloger

ratna

Source

https://link.springer.com/10.1007/978-3-319-15805-1

Validator

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