Benefit Risk Appraisal of Medicines A Systematic Approach to Decision Making

by Benefit Risk C. in Category Benefit Risk Appraisal on 2013-07-02 01:05:50, Revised

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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 Medicines establishes 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 8217 new model and analyses the implications of its implementation 8226 160 Describes an innovative systematic model which leads to transparent and responsible benefit risk decision making 8226 160 Contributes important ideas to the debate on benefit risk appraisal 8226 160 Provides a future framework for benefit risk appraisal of medicines Benefit Risk Appraisal of Medicines covers 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

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