Mostrar el registro sencillo del ítem
Bioequivalence Study of Two Long-Acting Formulations of Oxytetracycline Following Intramuscular Administration in Bovines
dc.contributor.author | Mestorino, Nora | |
dc.contributor.author | Marchetti, Maria Laura | |
dc.contributor.author | Lucas, Maria Florencia | |
dc.contributor.author | Modamio, Pilar | |
dc.contributor.author | Zeinsteger, Pedro | |
dc.contributor.author | Fernandez Lastra, Cecilia | |
dc.contributor.author | Segarra, Ignacio | |
dc.contributor.author | Mariño, Eduardo | |
dc.date.accessioned | 2019-10-02T10:57:56Z | |
dc.date.available | 2019-10-02T10:57:56Z | |
dc.date.issued | 2016-06-23 | |
dc.identifier.citation | Mestorino 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.2016.00050 | es |
dc.identifier.uri | http://hdl.handle.net/10952/4095 | |
dc.description.abstract | The 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.iso | en | es |
dc.publisher | Frontiers | es |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | Bioequivalence | es |
dc.subject | Pharmacokinetics | es |
dc.subject | Oxytetracycline | es |
dc.subject | Bovine | es |
dc.title | Bioequivalence Study of Two Long-Acting Formulations of Oxytetracycline Following Intramuscular Administration in Bovines | es |
dc.type | article | es |
dc.rights.accessRights | openAccess | es |
dc.journal.title | Frontiers in Veterinary Science | es |
dc.volume.number | 3 | es |
dc.issue.number | 50 | es |
dc.description.discipline | Farmacia | es |
dc.description.discipline | Medicina | es |
dc.identifier.doi | 10.3389/fvets.2016.00050 | es |