Additional studies are needed to further correlate pharmacokinetic/ pharmacodynamic parameters for many antibacterials with therapeutic efficacy in a variety of animal infection models and in human infections.
The results of more recent studies suggest that the magnitude of the pharmacokinetic/pharmacodynamic parameters required for efficacy are relatively similar in animal infection models and in human infections. These differences in pharmacodynamic activity have implications for optimal dosage regimens. Investigations over the past 20 years have demonstrated that antibacterials can vary markedly in the time course of antimicrobial activity. A 0.25 μg/ml breakpoint can be set as minimum effective plasma concentration for amoxicillin hence the generic preparation requires a dose interval of eight h. 30 μg h/ml and Cmax 2.9 ± 0.17 μg/ml for the reference one. In accordance with international standards, it was found that the generic preparation failed to be bioequivalent, i.e: AUC0∞ 9.08 ± 0.26 μg h/ml and Cmax 5.48 ± 0.19 μg/ml for the generic preparation vs AUC0∞ 13.28 ± 0. Statistical analysis of pharmacokinetic variables was carried out by ANOVA and Bonferroni t test, setting a P < 0.05. Pharmacokinetic analysis was carried out with a noncompartmental model. A composite determination of amoxicillinpotassium clavulanate concentration in each sample of plasma was carried out in triplicate, using a microbiological agar diffusion analysis.
The oral pharmacokinetic profiles of a single dose of each preparation were carried out in 12 adult mongrel dogs in a crossover model with a 10 day washout period at a dose of 12.5 mg/kg of trihydrate amoxicillin and potassium clavulanate as tablets.
#Intervalo de horas para la comida de un perro trial
The aim of this trial was to carry out a bioequivalence (BE) study in dogs using a generic preparation of amoxicillinpotassium clavulanate vs a commercially available reference preparation, both claiming to achieve plasma concentrations that allow a 12 h dosing interval after oral administration.
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