Референтные интервалы в репродуктивной токсичности крыс Вистар

Abstract

The need to risk assessment of reproductive and ontogenetic toxicity of a medicine depends on a number of factors such as the properties of the drug, indications for use and the target patient population. It should be noted that this type of research is widespread. To increase the reliability of the of research data interpretation, the evaluation of the results should include not only comparison with control values, but also with reference values obtained in the same test center. The purpose of the study was the creation of reference intervals for the main indicators evaluated in studies of developmental and reproductive toxicity for Wistar rats. To calculate the reference intervals, the data obtained in the course of research at RMC “HOME OF PHARMACY” in the period from 2015 to 2021. Animals of the control groups were used to calculate the reference intervals. All manipulations and experiments are approved by the bioethical commission. Prenatal development was assessed by indicators: the number of live and dead fetuses, corpus luteum, implantation sites, pre- and post-implantation death was calculated. In the postnatal period, body weight was measured weekly in rat pups, a number of physiological parameters and the rate of maturation of sensory-motor reflexes were evaluated. For the data, a nonparametric method for determining reference intervals was applied. The most variable indicators are the number of implantation sites, the percentage of pre- and post-implantation death and the time of testicular descent, which must be taken into account when analyzing the data obtained. It is shown that the values of reference intervals obtained by us are generally comparable with the literature data.