Alectinib product-specific bioequivalence guidance - Scientific guideline

This document provides product-specific guidance on the demonstration of the bioequivalence of alectinib hard capsule 150 mg.

Keywords: Bioequivalence, generics, alectinib

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

Alectinib hard capsule 150 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/790261/2018 Legal effective date: 01/04/2020

Overview of comments received on 'Alectinib hard capsule 150 mg product-specific bioequivalence guidance'

Reference Number: EMA/CHMP/582874/2019

Document history

Draft alectinib hard capsule 150 mg product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 08/02/2019 to 30/06/2019 Reference Number: EMA/CHMP/790261/2018