Dabrafenib product-specific bioequivalence guidance

This document provides product-specific guidance on dabrafenib.

Keywords: Bioequivalence, generics, dabrafenib 

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 version - effective 1 January 2026

Dabrafenib hard capsule 50 and 75 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/39771/2023 Legal effective date: 01/01/2026

Document history

Draft dabrafenib hard capsule 50 and 75 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 11/03/2024 to 30/06/2024 Reference Number: EMA/CHMP/39771/2023 Summary:

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Overview of comments received on ‘Dabrafenib hard capsule 50 and 75 mg product-specific bioequivalence guidance’ (EMA/CHMP/39771/2023)

Reference Number: EMA/339228/2024