Paliperidone palmitate depot suspension for injection (every 3 months) 175, 263, 350 and 525 mg product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, paliperidone

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

Paliperidone palmitate depot suspension for injection (every 3 months) 175, 263, 350 and 525 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/890768/2022 Legal effective date: 01/02/2025

Document history

Draft paliperidone palmitate depot suspension for injection (every 3 months) 175, 263, 350 and 525 mg product-specific bioequivalence guidance

Draft Consultation dates: 15/01/2024 to 30/04/2024 Reference Number: EMA/CHMP/890768/2022