The relevance of a metabolic profile analysis in the protocol of testing the bioequivalence of antihelmintic products on sheep

Abstract

The analysis of biochemical blood indices is essential for testing the bioequivalence and drug bioavailability. The purpose of this study is to analyze the relevance of the metabolic profile as an indicator of health on a sheep sample and the bioequivalence testing of two anthelmintic products in view of interchanging them in therapeutic practice. The research required a sample of 36 clinically healthy sheep. The sheep were selected on the premise of their health parameters being within the physiological, clinical and hematological indexes. One unicentric, randomized, cross-over with two-stage, two treatments and a pause were used in the test, including: initial screening and animal selection, phase I, washout, phase II, and final screening. Determination of blood biochemical indexes was performed during initial and final screening and consisted of blood samples (on EDTA) by automatic method, with VetScan analyzer and Large Animal Profile kits, including: ALP-alkaline phosphatase (U / L), AST (U / L), GGT-gammaglutamyltransferase (U / L), BUN-ureic nitrogen in the blood (mmol / L), total protein (g / L), GLOB-globulins (g / L), Ca-calcium (mmol / L), P-phosphorus (mmol / L), Mg - Magnesium (mmol / L). The results obtained revealed significant oscillations of most of the biochemical blood indices, but within the physiological range of the species and age, with some exceptions. Deviations consisted of ALP, CK and albumin slightly rising above the upper physiological limits, which we associated with stress-induced manipulation. Considering that the physical effort intensifies the CK activity, we attribute the higher values recorded in some sheep to the muscular effort generated by the natural grazing and the manipulation during the test. On the other hand, the slight increases in albuminemia correlated with dehydration. The integration of the values obtained in the evaluation of the biochemical blood indexes in the results of the clinical, haematological and statistical parameters was the confirmation that the sheep's health was in accordance with the requirements imposed by the protocol elaborated for the bioequivalence testing of the anthelmintic products tested.