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

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