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Is the demonstration of bioequivalence for clavulanic acid required in amoxicillin–clavulanic acid orally administered immediate‐release products?

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Bioequivalence (BE) criteria for amoxicillin–clavulanic acid (Co‐amoxiclav) oral formulations are based on 90% confidence interval for both amoxicillin and clavulanic acid. The aim of this work is to explore the… Click to show full abstract

Bioequivalence (BE) criteria for amoxicillin–clavulanic acid (Co‐amoxiclav) oral formulations are based on 90% confidence interval for both amoxicillin and clavulanic acid. The aim of this work is to explore the relevance of demonstrating BE of clavulanic acid in Co‐amoxiclav oral formulations and also to assess the impact on safety and efficacy of product due to bioinequivalent clavulanic acid.

Keywords: demonstration bioequivalence; clavulanic acid; amoxicillin clavulanic; acid; bioequivalence clavulanic

Journal Title: Journal of Pharmacy and Pharmacology
Year Published: 2018

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