Téléchargez le livre : Benefit-Risk Assessment of Medicines

Benefit-Risk Assessment of Medicines

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

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Éditeur :

Adis


Paru le : 2015-04-21



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Description

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.
Pages
317 pages
Collection
n.c
Parution
2015-04-21
Marque
Adis
EAN papier
9783319158044
EAN PDF
9783319158051
Informations sur l'ebook
Nombre pages copiables
3
Nombre pages imprimables
31
Taille du fichier
18074 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
52,74 €
EAN EPUB
9783319158051
Informations sur l'ebook
Nombre pages copiables
3
Nombre pages imprimables
31
Taille du fichier
11387 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
52,74 €

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