Levodopa/carbidopa/entacapone product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of levodopa, carbidopa and entacapone.

Keywords: Bioequivalence, generics, levodopa, carbidopa, entacapone

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

Levodopa/Carbidopa/Entacapone film-coated tablet 200 mg/50 mg/200 mg, 175 mg/43.75 mg/200 mg, 150 mg/37.5 mg/200 mg, 125 mg/31.25 mg/200 mg, 100 mg/25 mg/200 mg, 75 mg/18.75 mg/200 mg and 50 mg/12.5 mg/200 mg product-spe...

Adopted Reference Number: EMA/CHMP/805630/2016 Legal effective date: 01/07/2017

Document history - First version (current)

Levodopa/Carbidopa/Entacapone film-coated tablet 200 mg/50 mg/200 mg, 175 mg/43.75 mg/200 mg, 150 mg/37.5 mg/200 mg, 125 mg/31.25 mg/200 mg, 100 mg/25 mg/200 mg, 75 mg/18.75 mg/200 mg and 50 mg/12.5 mg/200 mg product-spe...

Adopted Reference Number: EMA/CHMP/805630/2016 Legal effective date: 01/07/2017

Overview of comments received on Levodopa/Carbidopa/Entacapone film-coated tablet 200 mg/50 mg/200 mg, 175 mg/43.75 mg/200 mg, 150 mg/37.5 mg/200 mg, 125 mg/31.25 mg/200 mg, 100 mg/25 mg/200 mg, 75 mg/18.75 mg/200 mg and...

Reference Number: EMA/CHMP/620297/2016

Draft Levodopa/Carbidopa/Entacapone film-coated tablet 200mg/50mg/200mg, 175mg/43.75mg/200mg, 150mg/37.5mg/200mg, 125mg/31.25mg/200mg, 100mg/25mg/200mg, 75mg/18.75mg/200mg and 50mg/12.5mg/200mg product-specific bioequiva...

Draft: consultation closed Consultation dates: 02/05/2016 to 31/07/2016 Reference Number: EMA/CHMP/162889/2016