Levothyroxine product-specific bioequivalence guidance
Table of contents
This document provides product-specific guidance on the demonstration of the bioequivalence of levothyroxine.
Key words: Bioequivalence, generics, levothyroxine
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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' (PDF/158.88 KB)
Adopted
First published: 16/12/2020
EMA/CHMP/532756/2020 -
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Draft Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg (and additional strengths) and 200 mcg product-specific bioequivalence guidance (PDF/159.16 KB)
Draft: consultation closed
First published: 15/06/2020
Consultation dates: 15/06/2020 to 30/09/2020
EMA/CHMP/176098/2020
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