Influence of serial blood sampling on total blood volume and complete blood count in Siberian Husky dogs during bioequivalence testing of an anthelmintic

Abstract

Serial blood sampling is essential for the assessment of the bioavailability of active molecules, which is the basis for the bioequivalence testing of medicinal products. In some canine breeds, including Siberian Husky (SH), serial blood sampling may be influenced by the total blood volume and other morpho-physiological and behavioral characteristics. This research was foscused on the analysis of the suitability of Siberian Husky dogs for serial blood sampling by phlebocentesis, to determine the plasma concentrations that are required for drug bioequivalence studies. In this regard, we resort to the analysis of serial blood sampling (n=72) influence on hematological indices and total blood volume in a SH dogs batch (n=22) during the bioequivalence testing of a canine anthelmintic product, based on a single-centered protocol (randomized, crossed, two-sequenced, two treatments and a 30 days break). The maximum volume of blood collected daily reached 85 mL/animal on the first day of the two phases, to be reduced as the test advanced, reaching a total of 310 mL blood/test/animal. The serial blood samples collected during the entire testing period represented 16.23% out of the mean value of the total blood volume (1909 mL blood/animal) for an average weight of 22.2 kg. By comparison with the possibility of taking 3 units of blood (450 mL/unit)/year from a canine donor of 20-25kg, we appreciate the good suitability of SH dogs for serial blood sampling, which was also confirmed by the evolution within the physiological range of hematological indices, with statistically insignificant deviations between the initial and final screening.