Levothyroxine product-specific bioequivalence guidance

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

Key words: Bioequivalence, generics, levothyroxine

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

Revision 1

Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg and 200 mcg (and additional strengths within the range) product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/123366/2025 Rev. 1 Legal effective date: 01/11/2025

Current version

Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg and 200 mcg (and additional strengths within the range) product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/176098/2020

Document history

Overview of comments received on 'Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg (and additional strengths) and 200 mcg product-specific bioequivalence guidance'

Adopted Reference Number: EMA/CHMP/532756/2020

Draft Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg (and additional strengths) and 200 mcg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 15/06/2020 to 30/09/2020 Reference Number: EMA/CHMP/176098/2020 Summary:

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

Abbreviations:

• BCS Classification: Biopharmaceutics Classification System
• AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
• AUC0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
• Cmax: maximum plasma concentration