Dabigatran etexilate product-specific bioequivalence guidance

Current version	Adopted guideline
Reference number	EMA/CHMP/805498/2016
Published	22/12/2016
Effective from	01/12/2018
Keywords	Bioequivalence, generics, dabigatran etexilate
Description	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.
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