Lurasidone product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of Lurasidone film-coated tablets 18.5, 37 and 74 mg.

Keywords: Bioequivalence, generics, lurasidone

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

Lurasidone film-coated tablets 18.5, 37 and 74 mg 4 product-specific bioequivalence guidance - Revision 1

AdoptedReference Number: EMA/CHMP/39336/2023 Rev. 1Legal effective date: 01/11/2025

English (EN) (138.8 KB - PDF)

First published: 30/06/2025

Lurasidone film-coated tablets 18.5, 37 and 74 mg 4 product-specific bioequivalence guidance

Reference Number: EMA/CHMP/39336/2023Legal effective date: 01/06/2024

English (EN) (137.37 KB - PDF)

First published: 28/11/2023

Lurasidone film-coated tablets 18.5, 37 and 74 mg 4 product-specific bioequivalence guidance

Draft: consultation closedConsultation dates: 22/06/2023 to 30/09/2023Reference Number: EMA/CHMP/39336/2023

English (EN) (156.88 KB - PDF)

First published: 22/06/2023