employee
CSCSTI 68.41
General information: fluralaner is a systemic ectoparasiticide that provides long-term control of fleas and ticks in dogs after a single oral administration. Based on this compound, VETSTEM LLC has developed a new veterinary medicinal product, VEPRIPAK®. Objective: to evaluate the pharmacokinetic bioequivalence of the test generic product VEPRIPAK® and the reference product BRAVECTO® in dogs. Results: analysis of serum fluralaner concentrations by HPLC–MS/MS demonstrated equivalence of key pharmacokinetic parameters: the mean time to maximum concentration (Tmax) was 48 h for both products; peak serum (or plasma, if per protocol) concentrations (Cmax) were 7,958.6 ng/mL for the test product and 7,987.0 ng/mL for the reference product. The 90% confidence intervals for the ratios CmaxT/CmaxR and AUC0–tT/AUC0–tR were within the bioequivalence acceptance range of 80.00–125.00 %. Conclusions: these data provide sufficient evidence to conclude that the test product is pharmacokinetically equivalent to the reference product in dogs.
fluralaner, VEPRIPAK®, BRAVECTO®, pharmacokinetics, bioequivalence, dogs
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