Benefit-Risk Assessment of Medicines

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

  • James Leong
  • Sam Salek
  • Stuart Walker

Table of contents

  1. Front Matter
    Pages i-xiii
  2. James Leong, Sam Salek, Stuart Walker
    Pages 1-22
  3. James Leong, Sam Salek, Stuart Walker
    Pages 23-31
  4. James Leong, Sam Salek, Stuart Walker
    Pages 69-143
  5. James Leong, Sam Salek, Stuart Walker
    Pages 145-176
  6. James Leong, Sam Salek, Stuart Walker
    Pages 229-291
  7. James Leong, Sam Salek, Stuart Walker
    Pages 293-306
  8. Back Matter
    Pages 307-317

About this book


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.


Benefit-risk assessment Decision-making Effective communication Regulatory authorities Universal framework

Authors and affiliations

  • James Leong
    • 1
  • Sam Salek
    • 2
  • Stuart Walker
    • 3
  1. 1.Centre of Regulatory ExcellenceDuke-NUS Graduate Medical SchoolSingaporeSingapore
  2. 2.Department of PharmacyUniversity of HertfordshireHatfieldUnited Kingdom
  3. 3.Centre for Innovation in Regulatory SciencesLondonUnited Kingdom

Bibliographic information

  • DOI
  • Copyright Information Springer International Publishing Switzerland 2015
  • Publisher Name Adis, Cham
  • eBook Packages Medicine
  • Print ISBN 978-3-319-15804-4
  • Online ISBN 978-3-319-15805-1
  • Buy this book on publisher's site