Palbociclib product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, palbociclib

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

Palbociclib hard capsule 75 mg, 100 mg and 125 mg and film-coated tablet 75 mg, 100 mg and 125 mg product-specific bioequivalence guidance - Revision 1

Reference Number: EMA/CHMP/802679/2018 Rev.1 Corr. Legal effective date: 01/04/2022

Document history

Overview of comments received on 'Draft palbociclib hard capsule 75 mg, 100 mg and 125 mg and film-coated tablet 75 mg, 100 mg and 125 mg product-specific bioequivalence guidance - Revision 1'

Reference Number: EMA/CHMP/133838/2021

Draft palbociclib hard capsule 75 mg, 100 mg and 125 mg and film-coated tablet 75 mg, 100 mg and 125 mg product-specific bioequivalence guidance - Revision 1

Draft: consultation closed Consultation dates: 23/11/2020 to 28/02/2021 Reference Number: EMA/CHMP/802679/2018 Rev. 1 Corr. 1 Summary:

Palbociclib hard capsule 75 mg, 100 mg and 125 mg and film-coated tablet 75 mg, 100 mg and 125 mg product-specific bioequivalence guidance

Draft palbociclib hard capsule 75 mg, 100 mg and 125 mg product-specific bioequivalence guidance - First version

Draft: consultation closed Consultation dates: 08/02/2019 to 30/06/2019 Reference Number: EMA/CHMP/802679/2018