Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8410107 | Drug Discovery Today | 2017 | 5 Pages |
Abstract
Marketing authorisation application dossiers relating to medicinal products containing new active substances and evaluated by the European Medicines Agency (EMA) over the period 2012-2015 were examined. Major objections and other concerns relating to efficacy and safety of the day 80 assessment reports were reviewed. Overall, approved products have more subgroup concerns than nonapproved products, which seems to be a consistent pattern. Subgroup analyses are mainly assessed to have the insurance that subgroups of patients that might lack a positive benefit: risk ratio will not be wrongly included in the approved treatment indication.
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Authors
Julien Tanniou, Steven Teerenstra, Sagal Hassan, Andre Elferink, Ingeborg van der Tweel, Christine Gispen-de Wied, Kit C.B. Roes,