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Benefit Risk Appraisal of Medicines

04 Tachwedd 2009

Benefit-Risk Appraisal of Medicines book

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.

Now a new book, co-authored by Professor Sam Salek of the Welsh School of Pharmacy, brings together a new pioneering tool for the assessment of benefits and risks for new medicines in development.

The book, Benefit Risk Appraisal of Medicines: A Systematic Approach to Decision Making, is written by Professor Salek in collaboration with Professor Stuart Walker, CMR International Institute for Regulatory Science, and Dr Filip Mussen, Johnson & Johnson Pharmaceutical Research and Development, Belgium.

Benefit Risk Appraisal of Medicines utilises a multi-criteria decision analysis which involves selecting, scoring and weighting key benefit and risk attributes and leads to an overall appraisal of benefits and risks of medicines.

Published by Wiley-Blackwell, Benefit-Risk Appraisal of Medicines, establishes the background and criteria required to assess benefit and risk. It also reviews the current practices by regulatory authorities and the pharmaceutical industry, including currently available models. It outlines the development and evaluation of the authors’ pioneering benefit-risk assessment framework, which uses multi-criteria decision analysis, and analyses the implications of its implementation.

Professor Salek, Director of the School’s Centre for Socioeconomic Research, said: "This book, which has been developed through a decade of research and debate, represents the relevance of the research conducted at the Welsh School of Pharmacy to the real world and its impact on policy and practice."

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