Benefit-Risk Appraisal of Medicines: A systematic approach to decision-making
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 and their regulatory reviews. This model utilises a multi-criteria decision analysis which involves selecting, scoring and weighting key benefit and risk attributes and leads to an overall balanced appraisal benefits and risks of medicines.Benefit-Risk Appraisal of Medicinesestablishes the background and criteria required to assess benefit and risk in general and reviews the current practices by regulatory authorities and the pharmaceutical industry, including those models currently available. It outlines the development and evaluation of the authors’ new model and analyses the implications of its implementation.Describes an innovative, systematic model which leads to transparent and responsible benefit-risk decision makingContributes important ideas to the debate on benefit-risk appraisalProvides a future framework for benefit-risk appraisal of medicinesBenefit-Risk Appraisal of Medicinescovers the entire process from the discovery of new medicines to their review and post marketing. This book is ideal for all those who work in the pharmaceutical industry and regulatory authorities, as well as post-graduate students of pharmaceutical medicine and clinical pharmacology.