What doesn’t work with Phase IV studies? A real experience from an Ethics Committee

Phase IV studies are conducted in real-life conditions to expand the knowledge on the efficacy and safety of an approved drug. Carried out either in hospital or general practice setting, they can be distinguished in Phase IV trials and post-marketing surveillance studies. Limited information is avai...

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Bibliographic Details
Main Authors: F. Grigoletto, A. C. Frigo
Format: Article
Language:English
Published: University of Bologna 2013-05-01
Series:Statistica
Online Access:http://rivista-statistica.unibo.it/article/view/3592