Dabigatran etexilate product-specific bioequivalence guidance
This document provides product-specific guidance on the demonstration of the bioequivalence of dabigatran etexilate.
This document should be read in conjunction with the questions and answers on product-specific bioequivalence, point 4.12.
Keywords: Bioequivalence, generics, dabigatran etexilate
- 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
Overview of comments received on 'Dabigatran etexilate, hard capsules, 75 mg, 110 mg and 150 mg product-specific bioequivalence guidance' (PDF/87.4 KB)
First published: 26/06/2018
Last updated: 26/06/2018
Draft dabigatran etexilate, hard capsules, 75 mg, 110 mg and 150 mg product-specific bioequivalence guidance (PDF/135.61 KB)Draft: consultation closed
First published: 22/12/2016
Last updated: 22/12/2016
Consultation dates: 22/12/2016 to 31/03/2017