Benefit-Risk Appraisal of Medicines

Beschreibung

Benefit-risk assessment is at the centre of the approval processfor every new medicine. The ability to assess the risks of a newmedicine accurately and to balance these against the benefits themedicine could bring is critical for every regulatory authority andpharmaceutical company. Despite this there are very few tried andtested evaluative models currently available. The authors of this book have developed a new, pioneering toolfor the assessment of benefits and risks for new medicines indevelopment. This model utilises a multi-criteria decision analysiswhich involves selecting, scoring and weighting key benefit andrisk attributes and leads to an overall appraisal of benefits andrisks of medicines. Benefit-Risk Appraisal of Medicines establishes thebackground and criteria required to assess benefit and risk ingeneral and reviews the current practices by regulatory authoritiesand the pharmaceutical industry, including those models currentlyavailable. It outlines the development and evaluation of theauthors' new model and analyses the implications of itsimplementation. * Describes an innovative, systematic model which leads totransparent and responsible benefit-risk decision making * Contributes important ideas to the debate on benefit-riskappraisal * Provides a future framework for benefit-risk appraisal ofmedicines Benefit-Risk Appraisal of Medicines covers the entireprocess from the discovery of new medicines to their marketing andis ideal for all those who work in the pharmaceutical industry andregulatory authorities,, as well as post-graduate students ofpharmaceutical medicine and clinical pharmacology.

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Filip Mussen

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Medical Science Medizin Pharmacology & Pharmaceutical Medicine Pharmakologie u. Pharmazeutische Medizin

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