Olaparib product-specific bioequivalence guidance

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

Keywords: Bioequivalence, generics, olaparib

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 01/01/2023

Olaparib 100 mg & 150 mg film-coated tablets product-specific bioequivalence guidance

AdoptedLegal effective date: 01/01/2023Reference Number: EMA/CHMP/371470/2021

Document history

Draft olaparib 100 mg & 150 mg film-coated tablets product-specific bioequivalence guidance

Consultation dates: 16/12/2021 to 31/03/2022Draft: consultation closedSummary:

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Abbreviations:

• BCS Classification: Biopharmaceutics Classification System
• AUC0-t: area under the plasma concentration curve from administration to last observed concentration at time t
• AUC0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
• Cmax: maximum plasma concentration