Abstract
Objective: The aim of this study is to evaluate the bioequivalence of a generic product containing tilmicosin phosphate in comparison to the original preparation. Material and Method: The original and generic products were applied to 20 healthy Kivircik sheep at a single dose (10 mg/kg, s.c.) according to a cross- over design. Blood samples were taken before and at 15 and 30th minutes and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96th hours following injections. The serum concentrations of tilmicosin were measured by high pressure liquid chormatography (HPLC) following extraction process. Pharmacokinetic parameters were calculated using non-compartmental model analysis. AUC (0-72) and Cmax were based basis for evaluation of bioequivalence. The bioequivalence criterion was AUC 80-125 % (90 % confidence interval). Result: Compared to the original product, AUC (0-72) of the generic product was 105,7% and the Cmax was 106,6%. Conclusion: It is concluded that the two products are bioequivalent and could be used interchangeably in conditions where they are indicated.
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