Nilotinib product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of nilotinib hard capsules 50, 150 and 200 mg.

Keywords: Bioequivalence, generics, nilotinib

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

Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/518671/2023

Document history

Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 25/06/2024 to 30/09/2024 Reference Number: EMA/CHMP/518671/2023 Summary:

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

Overview of comments received on `Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance’ (EMA/CHMP/518671/2023)

Reference Number: EMA/479330/2024