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

Highlights • 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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Bibliographic Details
Published in:International journal of antimicrobial agents 2016-12, Vol.48 (6), p.753-756
Main Authors: de Mattos, Livia I.S, Ferraris, Fausto K, Machado, Tiago S.C, de Brito, Thais M, Chaves, Amanda S, Pereira, Heliana M, Pinto, Douglas P, da Silva, Diego M.D, Amendoeira, Fabio C
Format: Article
Language:English
Subjects:
Amoxicillin
Amoxicillin - administration & dosage
Amoxicillin - pharmacokinetics
Amoxicillin - pharmacology
Animals
Anti-Bacterial Agents - administration & dosage
Anti-Bacterial Agents - pharmacokinetics
Anti-Bacterial Agents - pharmacology
Bioavailability
Bioequivalence
Drugs, Generic - administration & dosage
Drugs, Generic - pharmacokinetics
Drugs, Generic - pharmacology
Humans
Infectious Disease
Male
Pharmacokinetics
Product Surveillance, Postmarketing
Quality control
Rats
Rats, Wistar
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Description
Summary:Highlights • 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.
ISSN:0924-8579
1872-7913
DOI:10.1016/j.ijantimicag.2016.09.019