Benefit-Risk Assessment of Medicines The Development and Application of a Universal Framework for Decision-Making and Effective Communication /
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 benefi...
| Published in: | Springer eBooks |
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| Main Authors: | , , |
| Corporate Author: | |
| Format: | eBook |
| Language: | English |
| Published: |
Cham :
Springer International Publishing : Imprint: Adis,
2015.
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| Subjects: | |
| Online Access: | http://dx.doi.org/10.1007/978-3-319-15805-1 Перейти в каталог НБ ТГУ |
Table of Contents:
- Prologue
- Preface
- Overview
- Approaches to utilising decision-making framework
- Benefit-risk assessment of medicines by pharmaceutical companies and regulatory authorities
- Development of a universal benefit-risk framework and template
- Implementation of the benefit-risk assessment template by mature agencies
- Implementation of the benefit- risk summary template by a maturing agency: A case study
- Communicating benefit-risk decisions by US FDA, EMA, TGA and Health Canada
- Conclusions and future directions
- References.