Sitagliptin product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of sitagliptin.
Keywords: Bioequivalence, generics, sitagliptin
Abbreviations:
- BCS Classification: Biopharmaceutics Classification System
- AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
- AUC0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
- Cmax: maximum plasma concentration
-
List item
Overview of comments on Sitagliptin film-coated tablets 25, 50 and 100 mg product-specific bioequivalence guidance (PDF/79.74 KB)
First published: 07/04/2016
Last updated: 07/04/2016
EMA/CHMP/162917/2016 -
List item
Draft sitagliptin film-coated tablets 25, 50 and 100 mg product-specific bioequivalence guidance (PDF/106.71 KB)
Draft: consultation closed
First published: 15/07/2015
Last updated: 15/07/2015
Consultation dates: 15/07/2015 to 01/11/2015
EMA/CHMP/PKWP/36869/2015