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Benefit-Risk Assessment of Medicines

The Development and Application of a Universal Framework for Decision-Making and Effective Communication

Produktform: Buch / Einband - fest (Hardcover)

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.weiterlesen

Sprache(n): Englisch

ISBN: 978-3-319-15804-4 / 978-3319158044 / 9783319158044

Verlag: Springer International Publishing

Erscheinungsdatum: 05.05.2015

Seiten: 317

Auflage: 1

Autor(en): Stuart Walker, Sam Salek, James Leong

53,49 € inkl. MwSt.
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