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Benefit-Risk Assessment of Medicines
The Development and Application of a Universal Framework for Decision-Making and Effective Communication
James Leong, Sam Salek, Stuart Walker
Paperback | Engels
€ 52,95
+ 105 punten
Uitvoering
Omschrijving
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.Specificaties
Betrokkenen
- Auteur(s):
- Uitgeverij:
Inhoud
- Aantal bladzijden:
- 317
- Taal:
- Engels
Eigenschappen
- Productcode (EAN):
- 9783319367675
- Verschijningsdatum:
- 13/10/2016
- Uitvoering:
- Paperback
- Formaat:
- Trade paperback (VS)
- Afmetingen:
- 156 mm x 234 mm
- Gewicht:
- 467 g
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