Erlotinib product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of erlotinib. Please note that no comments have been received for this guideline during the public consultation period.

AbbreviationsAbbreviationsAbbreviations:

• 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

Keywords: Bioequivalence, generics, erlotinibBioequivalence, generics, erlotinibBioequivalence, generics, erlotinibBioequivalence, generics, erlotinib

Current effective version

Erlotinib film-coated tablets 25, 100 and 150 mg product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/675840/2014 Legal effective date: 01/06/2015 Summary:

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

Document history

Draft erlotinib product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 15/11/2013 to 15/02/2014 Reference Number: CHMP/PKWP/EMA/418988/2013 Summary:

Erlotinib product-specific bioequivalence guidance

Related content

• Product-specific bioequivalence guidance
• Investigation of bioequivalence