Post-marketing surveillance of generic amoxicillin using a microbiological assay and pharmacokinetic approach in rats.

Livia I S de Mattos,Fausto K Ferraris, Tiago S C Machado, Thais M de Brito, Amanda S Chaves,Heliana M Pereira,Douglas P Pinto, Diego M D da Silva,Fabio C Amendoeira

International Journal of Antimicrobial Agents（2016）

引用 2|浏览14

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摘要

•Post-marketing surveillance of generic antibiotics is not effective to detect quality deviations.•Need for review and development of other approaches to QC for generic drugs.•Pharmacokinetic tests in rats in association with microbiological potency assay proposed.

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关键词

Amoxicillin,Pharmacokinetics,Bioavailability,Bioequivalence,Quality control,Rats

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