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dc.contributor.authorMestorino, Nora
dc.contributor.authorMarchetti, Maria Laura
dc.contributor.authorLucas, Maria Florencia
dc.contributor.authorModamio, Pilar
dc.contributor.authorZeinsteger, Pedro
dc.contributor.authorFernandez Lastra, Cecilia
dc.contributor.authorSegarra, Ignacio
dc.contributor.authorMariño, Eduardo
dc.date.accessioned2019-10-02T10:57:56Z
dc.date.available2019-10-02T10:57:56Z
dc.date.issued2016-06-23
dc.identifier.citationMestorino N, Marchetti ML, Lucas MF, Modamio P, Zeinsteger P, Fernández Lastra C, Segarra I and Mariño EL (2016) Bioequivalence Study of Two Long-Acting Formulations of Oxytetracycline Following Intramuscular Administration in Bovines. Front. Vet. Sci. 3:50. doi: 10.3389/fvets.2016.00050es
dc.identifier.urihttp://hdl.handle.net/10952/4095
dc.description.abstractThe aim of this study was to evaluate the bioequivalence of two commercial long-acting formulations based on oxytetracycline (OTC) hydrochloride between the reference formulation (Terramycin LA, Pfizer) and a test formulation (Cyamicin LA, Fort Dodge Saude Animal). Both formulations were administered in a single intramuscular route at a dose of 20 mg OTC/kg of body weight in clinically healthy bovines. The study was carried out according to a one-period parallel design. Plasma samples were analyzed by high-pressure liquid chromatography. The limit of quantitation was 0.050 μg/mL with an accuracy of 101.67% with a coefficient of variation of 13.15%. Analysis of variance and 90% confidence interval tests were used to compare the bioavailability parameters (maximum plasma concentration, Cmax, and the area under the concentration-versus-time curve extrapolated to infinity, AUC0–∞) of both products. In the case of the time to maximum concentration (Tmax), non-parametric tests based on Wilcoxon’s signed rank test were preferred. The comparison of the mean AUC0–∞ values did not reveal any significant differences (311.40 ± 93.05 μg h/mL and 287.71 ± 45.31 μg h/mL, respectively). The results were similar for the Tmax (3.58 ± 0.90 h versus 3.42 ± 0.51 h). However, when comparing the mean Cmax some significant differences were found (8.73 ± 3.66 μg/mL and 10.43 ± 3.84 μg/mL, respectively). The 90% confidence intervals for the ratio of AUC0–∞ and Tmax values for the reference and test product are within the interval 80–125%, but the 90% confidence intervals for the ratio of Cmax falls outside the proposed interval. It was concluded that Cmax of test product are not within the 20% of those of the reference, thus suggesting that test OTC is not bioequivalent to the reference formulation.es
dc.language.isoenes
dc.publisherFrontierses
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.subjectBioequivalencees
dc.subjectPharmacokineticses
dc.subjectOxytetracyclinees
dc.subjectBovinees
dc.titleBioequivalence Study of Two Long-Acting Formulations of Oxytetracycline Following Intramuscular Administration in Bovineses
dc.typearticlees
dc.rights.accessRightsopenAccesses
dc.journal.titleFrontiers in Veterinary Sciencees
dc.volume.number3es
dc.issue.number50es
dc.description.disciplineFarmaciaes
dc.description.disciplineMedicinaes
dc.identifier.doi10.3389/fvets.2016.00050es


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Attribution-NonCommercial-NoDerivatives 4.0 Internacional
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