Aprepitant product-specific bioequivalence guidance - Scientific guideline

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

Keywords: Bioequivalence, generics, aprepitant

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 - effective 1 January 2026

Aprepitant, hard capsules, 80mg, 125mg, 80+125mg and powder for oral suspension 125mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/13174/2025 Legal effective date: 01/01/2026

First version

Draft aprepitant, hard capsules, 80mg, 125mg, 80+125mg and powder for oral suspension 125mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 31/01/2025 to 30/04/2025 Reference Number: EMA/13174/2025 Summary:

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.