Preclinical studies its a significant part of the registration dossier, formed for the purpose of state registration of a new medicinal product (MP). The assessment of the endocrine status is not significantly defined in the requirements of regulatory documents for assessing the safety of a pharmaceutical agent. However, it is important to evaluate drugs being developed for the pharmaceutical market for their potential impact on a given system and compare them with the norms described in the literature. Somatotropin (STH, growth hormone) is one of the hormones, the assessment of the effect on which is important at the stage of preclinical studies of drugs. Growth hormone is responsible for bone growth, organ development, metabolism, energy homeostasis and also one of the factors regulating puberty and fertility in men and women. However, the norms of STH in laboratory animals used in preclinical studies are very little covered. In this study we assessed the level of somatotropin in the peripheral blood of intact laboratory outbred female mice aged 2 to 8 weeks. Also, a morphometric analysis state of the ovaries in animals was carried out within of this experiment. According to the results of the study, concentration of STH in the outbred female mice blood is from 0 to 3 ng / ml. The maximum concentration of STH in female mice blood plasma was recorded at the age of 3 weeks (2.79 ± 0.34 (SD) ng / ml). The level of the hormone decreased with increasing age of the animal, and by 6 weeks ages it was 0.76 ± 0.14 ng / ml. The experimental evidence the level of STH at the onset of puberty (approximately 12 days) and the average age of onset of puberty in female mice (from 8 to 13 years) are compatible. Based on the evaluating the morphometric parameters of ovaries, puberty occur in female mice at the age of 8 weeks. At 8 weeks, against of decrease in the level of STH, antral (tertiary) follicles and yellow bodies develop in the ovaries in all animals. It will be interested evaluation hormone level in uneven-aged outbredmale mice and other animal species including non-rodents (rabbits, minipigs, dogs) for more information and development of STH reference intervals.
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The study was performed without external funding.
A.E. Katelnikova – study concept and design, writing of the text
E.I. Trofimets – study concept and design, data collection
A.A. Matichin – study concept and design, editing of the text
N.M. Faustova – data collection and analysis
Y.A. Gushchindata collection and analysis
M.N. Makarova – idea of the research, editing of the text
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