Table of Contents

Concept and scope of benefit-risk evaluation of medicines.
Criteria for a benefit-risk model : a conceptual framework.
Review of the current benefit-risk assessment models.
Defining a systematic approach to decision making.
Development and application of a benefit-risk assessment model based on multi-criteria decision analysis.
A future framework for benefit-risk appraisal of medicines. Benefit-risk assessment is at the centre of the approval process for every new medicine. The ability to assess the risks of a new medicine accurately and to balance these against the benefits the medicine could bring is critical for every regulatory authority and pharmaceutical company. Despite this there are very few tried and tested evaluative models currently available. The authors of this book have developed a new, pioneering tool for the assessment of benefits and risks for new medicines in development. This model utilises a multi-criteria decision analysis which involves selecting, scori.