Clinical and non-clinical evaluation during the consultation procedure on medicinal substances contained in drug-eluting (medicinal-substance-eluting) coronary stents - Scientific guideline

HumanScientific guidelines

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

Current effective version

Guideline on clinical and non-clinical evaluation during the consultation procedure on medicinal substances contained in drug-eluting (medicinal substance-eluting) coronary stents

Adopted Reference Number: EMEA/CHMP/EWP/110540/2007 Legal effective date:

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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

Reference Number: EMEA/CHMP/EWP/242067/2008

English (EN) (165.56 KB - PDF)

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Draft guideline on the development medicinal substances contained in drug-eluting (medicinal substance-eluting) coronary stents

Draft: consultation closed Reference Number: EMEA/CHMP/EWP/110540/2007

English (EN) (68.67 KB - PDF)

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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...

Reference Number: EMEA/CHMP/EWP/56477/2006

English (EN) (45.08 KB - PDF)

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