Benefit-Risk Assessment of Medicines The Development and Application of a Universal Framework for Decision-Making and Effective Communication /

• Main Authors: Leong, James (Author), Salek, Sam (Author), Walker, Stuart (Author)
• Corporate Author: SpringerLink (Online service)
• Format: Electronic eBook
• Language: English
• Published: Cham : Springer International Publishing : Imprint: Adis, 2015.
• Subjects: Medicine.; Medical research.; Pharmacy.; Quality of life.; Medicine & Public Health.; Drug Safety and Pharmacovigilance.; Quality of Life Research.

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...

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.