Benefit-risk assessment of medicines [electronic resource] : the development and application of a universal framework for decision-making and effective communication / James Leong, Sam Salek, Stuart Walker ; foreword by Hans-Georg Eichler.
2015
RM301.27
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Title
Benefit-risk assessment of medicines [electronic resource] : the development and application of a universal framework for decision-making and effective communication / James Leong, Sam Salek, Stuart Walker ; foreword by Hans-Georg Eichler.
ISBN
9783319158051 electronic book
3319158058 electronic book
9783319158044
3319158058 electronic book
9783319158044
Published
Cham : Springer, [2015]
Language
English
Description
1 online resource
Item Number
10.1007/978-3-319-15805-1 doi
Call Number
RM301.27
Dewey Decimal Classification
615/.1901
Summary
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. In view of this a universal framework together with an appropriate documentation system for recording benefit-risk decisions has been developed and applied and is a valuable addition to the Benefit-Risk Toolbox. The opportunity to examine the implementation of this approach by several regulatory authorities places this book in a unique position with the potential to positively contribute to 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 also reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Therefore, this is not an attempt to provide a comprehensive and complete account of the current benefit-risk assessment environment; rather, the strength of this book is that it provides an evaluation of some current approaches to the benefit-risk assessment of medicines and outlines the development of a new universal framework. It also demonstrates how a number of mature agencies have implemented this universal framework together with the methodology for documenting their benefit-risk decisions. In addition, it also reviews current publicly available documents together with their strengths and weaknesses in communicating benefit-risk decisions to stakeholders.
Bibliography, etc. Note
Includes bibliographical references.
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Print version: 9783319158044
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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.
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.