Pirfenidone product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of Pirfenidone film-coated tablets 267, 537 and 801 mg, and hard capsules 267 mg.

Keywords: Bioequivalence, generics, Pirfenidone

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 from 01/06/2024

Pirfenidone film-coated tablets 267, 537 and 801 mg, and hard capsules 267 mg product-specific bioequivalence guidance

AdoptedLegal effective date: 01/06/2024Reference Number: EMA/CHMP/901584/2022

Document history

Pirfenidone film-coated tablets 267, 537 and 801 mg, and hard capsules 267 mg product-specific bioequivalence guidance

Consultation dates: 22/06/2023 to 30/09/2023Draft: consultation closedReference Number: EMA/CHMP/901584/2022

Related content

• Product-specific bioequivalence guidance
• Investigation of bioequivalence