Clinical and non-clinical evaluation during the consultation procedure on medicinal substances contained in drug-eluting (medicinal-substance-eluting) coronary stents - Scientific guideline
Table of contents
This document addresses the clinical and non-clinical aspects of the evaluation of ancillary medicinal substances contained in a drug-eluting coronary stents.
Keywords: Drug eluting stents, non-clinical safety, clinical safety
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Overview of comments received on draft guideline on the development medicinal substances contained in drug-eluting (medicinal substance-eluting) coronary stents (PDF/165.56 KB)
First published: 24/07/2008
Last updated: 24/07/2008
EMEA/CHMP/EWP/242067/2008 -
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Draft guideline on the development medicinal substances contained in drug-eluting (medicinal substance-eluting) coronary stents (PDF/68.67 KB)
Draft: consultation closed
First published: 22/03/2007
Last updated: 22/03/2007
EMEA/CHMP/EWP/110540/2007 -
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Concept paper on the development of a CHMP guideline on the evaluation of non-clinical and clinical data on the medicinal substances contained in drug-eluting (medicinal substance-eluting) coronary stents within the fram... (PDF/45.08 KB)
First published: 23/02/2006
Last updated: 23/02/2006
EMEA/CHMP/EWP/56477/2006