BookJames Leong, Sam Salek, Stuart Walker ; foreword by Hans-Georg Eichler.
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.