Aliskiren product-specific bioequivalence guidance - Scientific guideline

This document provides product-specific guidance on the demonstration of the bioequivalence of aliskiren film-coated tablet 150 mg and 300 mg.

Keywords: Bioequivalence, generics, aliskiren

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 effective version

Aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance - Revision 1

Reference Number: EMA/151687/2025 Rev. 1*

Document history

Aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/291450/2018 Legal effective date: 01/07/2019

Overview of comments received on 'Aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance' (EMA/CHMP/291450/2018)

Reference Number: EMA/CHMP/681421/2018

Draft aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 27/06/2018 to 30/09/2018 Reference Number: EMA/CHMP/291450/2018

Draft aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance - Revision 1

Draft: consultation closed Consultation dates: 10/07/2025 to 31/10/2025 Reference Number: EMA/151687/2025 Rev. 1