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Pig Journal Volume: 51
Publication date: June 2003

Refereed Section

BIOEQUIVALENCE OF SIX GENERIC PREPARATIONS OF ENROFLOXACIN IN PIGS
L.H. Sumano, C.L. Ocampo and O.L. Gutierrez

Abstract
Given the importance of enrofloxacin in the treatment of bacterial diseases in pigs and the abundance of generic preparations available on the market, a bioequivalence study of 6 generic preparations of this drug and Baytril? was carried out. Forty-two non-medicated pigs were placed in groups of six and each preparation was injected IM at a 5 mg/kg bolus dose. Blood samples were obtained at various times and serum was recovered and analysed by a quantitative/qualitative microbiological agar diffusion analysis. Serum concentration/activity vs. time profiles and pharmacokinetic data derived from these curves, revealed lack of bioequivalence of all tested preparations. The reference enrofloxacin showed the highest AUC and Cpmax values (P< 0.05). The highest Cpmax average value of tested generics was only 46% of the reference enrofloxacin, 15% being the lowest value obtained. However, generic preparations were statistically indistinguishable in most instances. These results may partly explain different clinical outcomes and stress the need to carry out bioequivalence trials to register a new generic preparation.

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