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…
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Produktdetails
Weitere Autoren: Mussen, Filip / Salek, Sam
- ISBN: 978-0-470-74812-1
- EAN: 9780470748121
- Produktnummer: 13841914
- Verlag: Wiley
- Sprache: Englisch
- Erscheinungsjahr: 2009
- Seitenangabe: 304 S.
- Plattform: PDF
- Masse: 2'710 KB
Über den Autor
Dr Sam Salek, Reader in Pharmacoepidemiology, Director - WSP Centre for Socioeconomic Research; Director - Postgraduate Course in Pharmaceutical Medicine, Cardiff University, UK. Mr Filip Mussen, Johnson & Johnson Pharmaceuticals Research and Development, Belgium. Prof Stuart Walker, President and Founder, International Institute for Regulatory Science, UK.
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