Levodopa/carbidopa/entacapone product-specific bioequivalence guidance
Table of contents
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
- 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
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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... (PDF/144.17 KB)
Adopted
First published: 03/01/2017
Last updated: 03/01/2017
Legal effective date: 01/07/2017
EMA/CHMP/805630/2016 -
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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... (PDF/82.03 KB)
First published: 03/01/2017
Last updated: 03/01/2017
EMA/CHMP/620297/2016 -
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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... (PDF/80.06 KB)
Draft: consultation closed
First published: 02/05/2016
Last updated: 02/05/2016
Consultation dates: 02/05/2016 to 31/07/2016
EMA/CHMP/162889/2016