Tadalafil product-specific bioequivalence guidance - Scientific guideline

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

Keywords: Bioequivalence, generics, tadalafil

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 - Revision 3

Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance - Revision 3

Adopted Reference Number: EMA/CHMP/315234/2014 Rev.3 Legal effective date: 01/11/2025

Document history - Revision 2

Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance - Revision 2

Adopted Reference Number: EMA/CHMP/315234/2014 Rev.2 Legal effective date: 01/01/2024

Draft tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance - Revision 2

Draft: consultation closed Consultation dates: 04/04/2022 to 31/07/2022 Reference Number: EMA/CHMP/315234/2014 Rev.2 Summary:

This revision concerns defining what is meant by ‘comparable’ T_max as an additional main pharmacokinetic variable in the bioequivalence assessment section of the guideline.

Overview of comments received on 'Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance' (EMA/CHMP/315234/2014 Rev.2)

Reference Number: EMA/CHMP/779867/2022

Document history - Revision 1

Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance - Revision 1

Adopted Reference Number: EMA/CHMP/315234/2014 Rev.1 Legal effective date: 01/08/2018 Summary:

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

Overview of comments received on 'Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance' (EMA/CHMP/315234/2014/Rev.1) - First version

Reference Number: EMA/CHMP/644909/2017

Draft tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance - Revision 1

Draft: consultation closed Consultation dates: 03/08/2017 to 31/10/2017 Reference Number: EMA/CHMP/315234/2014/Rev. 1 Summary:

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

Document history - First version

Tadalafil film-coated tablets 2.5, 5, 10 and 20 mg product-specific bioequivalence guidance - First version

Adopted Reference Number: EMA/CHMP/315234/2014 Legal effective date: 01/12/2015 Summary:

This document provides product-specific guidance on demonstration of bioequivalence of tadalafil

Overview of comments received on 'draft tadalafil product-specific bioequivalence guidance' - First version

Reference Number: EMA/CHMP/116444/2014

Draft tadalafil product-specific bioequivalence guidance - First version

Draft: consultation closed Consultation dates: 15/11/2013 to 15/02/2014 Reference Number: CHMP/PKWP/EMA/423735/2013 Summary:

Tadalafil product-specific bioequivalence guidance