Telithromycin product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of telithromycin.

Keywords: Bioequivalence, generics, telithromycin

Abbreviations:

• BCS Classification: Biopharmaceutics Classification System
• AUC_0-t: area under the plasma concentration curve from administration to last observed concentration at time t
• AUC_0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
• C_max: maximum plasma concentration

Current effective version

Telithromycin film-coated tablets 400 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/315235/2014 Legal effective date: 01/12/2015 Summary:

This document provides product-specific guidance on demonstration of bioequivalence of telithromycin

Document history

Overview of comments received on 'draft telithromycin product-specific bioequivalence guidance'

Reference Number: EMA/CHMP/116814/2014

Draft telithromycin product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 15/11/2013 to 15/02/2014 Reference Number: CHMP/PKWP/EMA/422605/2013 Summary:

Telithromycin product-specific bioequivalence guidance