Methylphenidate product-specific bioequivalence guidance - Scientific guideline

This document provides product-specific guidance on the demonstration of the bioequivalence of methylphenidate.

Keywords: Bioequivalence, generics, methylphenidate

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

Methylphenidate, prolonged-release tablet 18 mg, 27 mg, 36 mg and 54 mg and modified release capsule 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 25/06/2024 to 30/09/2024 Reference Number: EMA/94136/2024 Summary:

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

Overview of comments received on `Methylphenidate, prolonged-release tablet 18 mg, 27 mg, 36 mg and 54 mg and modified release capsule 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg product-specific bioequivalence guidance’

Reference Number: EMA/479935/2024