From the regulatory point of view a strong link between an animal model and human pharmacodynamics of biological drugs is very important to qualify the model as “relevant”. Consistent changes in cell population between human physiology and animal model gain value of this model which then can be pharmacodynamically “relevant” from the regulatory point of view. Consequently, the aim of this study was to determine how similar to human observations is the effect of selected biological drugs on blood cells in a pig model. The study was to carry out a comparative analysis of the variability of selected biochemical and hematological parameters of the blood after administration of five different human therapeutic monoclonal antibodies (mAbs) after a single subcutaneous (SC) dose in breeding pigs. The tested drugs were siltuximab (Syl- vant®), omalizumab (Xolair®), infliximab (Inflectra®), pembrolizumab (Keytruda®), and vedoli- zumab (Entyvio®) given in a single 1 mg/kg SC injection. Each of the tested drugs exerted a sig- nificant effect on at least two of the tested parameters three weeks after the administration. Siltuximab significantly influenced 9 of the analyzed parameters. Vedolizumab significantly influenced 8 of the analyzed parameters. Infliximab had the lowest impact of all the tested drugs, as it significantly influenced only two of the analyzed parameters. The study has proved that the impact of mAbs on the analyzed parameters can be significantly extended over time. This requires the monitoring of hematological parameters in the pig model even many weeks af- ter administration of a drug in a relatively small dose.
The study was conducted on 26 male, 30 days-old goats, separated from their mothers, divided into two equal groups: I - control and II - experimental, consisting of 13 animals each. All animals were fed with milk replacer, experimental group received additionally 50 g/kg body weight, additive of HMB, for 60 days. The following features were analyzed: body weight, daily increases of body weight, as well as hematological and biochemical blood features. Differences in body weight were found, between experimental and control group, after 60 days of experiment 0.57 kg (p≤0.01). The daily weight gain of experimental animals was higher in comparison with control group. Significant differences were also noted in results of hematological and biochemical blood parameters. Experimental animals showed a higher level of red blood cells as well as number of lymphocytes in comparison with the control group, (p≤0.01).Significant changes were also observed in the level of triglycerides, inorganic phosphorus and protein between both groups. The acid-base balance parameters and ionogram, showed a higher pH level (p≤0.05) HCO – act., HCO – std., BE, ctCO , O sat, K+, Cl– (p≤0.01), while the anion gap (AG) and Na+ were significantly lower in control group (p≤0.01).