Tolvaptan product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of Tolvaptan tablets with the dose range 7.5, 15 and 30 mg and tolvaptan tablets with the dose range 15, 30, 45, 60 and 90 mg

Keywords: Bioequivalence, generics, tolvaptan

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

Tolvaptan tablets with the dose range 7.5, 15 and 30 mg and tolvaptan tablets with the dose range 15, 30, 45, 60 and 90 mg product-specific bioequivalence guidance

Reference Number: EMA/CHMP/254395/2024 Legal effective date: 01/09/2025

Overview of comments received on Tolvaptan tablets with the dose range 7.5, 15 and 30 mg and tolvaptan tablets with the dose range 15, 30, 45, 60 and 90 mg product-specific bioequivalence guidance

Reference Number: EMA/339228/2024

Document history

Tolvaptan tablets with the dose range 7.5, 15 and 30 mg and tolvaptan tablets with the dose range 15, 30, 45, 60 and 90 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 26/07/2024 to 31/10/2024 Reference Number: EMA/CHMP/254395/2024 Summary:

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