The article deals with descriptive statistics of data measured using qualitative (categorical) scales and criteria for determining the statistical significance of differences between samples. Special attention is paid to the problem of multiple comparisons of data measured using nominal scales. For each method, examples of data processing obtained in pharmacological studies are given.

The aim of the work was to develop an optimal scheme for the synthesis of substance of cyclo-L-prolylglycine neuropeptide (CPG), a potential drug useful for the integrated treatment of psychiatric pathologies, including anxiety, depressive disorders and cognitive impairment. Two 4-stage CPG synthesis schemes were considered. Both schemes led to a product with the same optical purity, comparable to the overall yield and time-consuming, however, the first scheme is 2.5 times more profitable in terms of the cost of basic reagents per 100 g of product. The first scheme was selected as the basis for the development of laboratory regulations. Also for the first time the anti-parkinsonian activity of CPG (0.05 and 0.5 mg/kg intraperitoneally) on a model of haloperidol catalepsy was detected.

Nadorova AV, Chernyakova IV, Kolik LG FSBI «Zakusov Institute of Pharmacology», Moscow Resume. Background. Numerous experimental and clinical data confirm the vulnerability of the adolescent brain to ethanol and the long-term cognitive effects of acute alcohol intoxication.Selank was synthesized on the base of modification of the endogenous regulatory peptide tuftsin and developed as an anxiolytic with the activating effect on mental and cognitive functions. The aim of this work was to study the selenk effects on ethanol-induced impairment in short-term memory in young rats. Methods. The effect of selank in an effective anxiolytic dose (0.3 mg/kg, i.p., twice) on ethanol-induced (3.0 g/kg, i.p., twice) memory impairment was registered in the "Novel object recognition" test in male PD35 aged rats. Results. Selank prevented ethanol-induced disturbance of short-term non-spatial memory in adolescent rats, significantly increasing the discrimination index (p < 0.01) and the recognition index (p < 0.01) of the new stimulus object. Selank per se has no statistically significant effect on memory consolidation phase in rats not exposed to alcohol. Conclusion. The obtained data suggest a corrective effect of heptapeptide analogue of taftsin on hippocampus-dependent cognitive impairment induced by alcohol.

While studing of experimental pharmacokinetics of the peptide analogues piracetam noopept - N-phenylacetyl-L-prolyl-glycine ethyl ester, was found the active metabolite that identificated as cyclo-L-prolylglycine (CPG). At that thime CPG was detected as the endogenous compound in plasma and brain. It was found that the pharmacokinetic parameters of CPG have the better characteristics than noopept and its prototype piracetam for the longer period of eliminations and the best bioavailability for the brain. It is found that the spectrum of nootropic and anxiolytic activity CPG and piracetam are composed. For piracetam also found antihypoxic and neuroprotective effects that were not investigated for CPG. Furthermore while studying of the pharmacological activity was found significant differences in the effective doses of comparable drugs that were no described by their different pharmacokinetics. This paper presents the results of comparative study of the antihypoxic and neuroprotective effects of CPG and piracetam in comparision wich pharmacokinetic parameters of studied compounds.

Justification. The prevalence of type 2 diabetes is extremely high, and the number of such patients is constantly increasing. In 30-40% of patients, only insulin therapy can achieve compensation for the disease. Therapy with ready-made mixtures is considered as an alternative option in the initiation and intensification of insulin therapy. Rinsulin® mix 30/70 is a domestic biosimilar (bioanalogue) of Humulin® M3, a combination of a 30% solution of human insulin and a 70% suspension of insulin-isofan. The clinical research program for biosimilars of insulin preparations includes pharmacology studies: pharmacokinetics, pharmacodynamics and clinical safety research. Purpose. Evaluation of the biosimilarity of Rinsulin® mix 30/70 (bioanalog) and Humulin® M3 (original) preparations in the conditions of hyperinsulinemic euglycemic clamp in healthy volunteers. Materials and methods. The study was conducted on healthy male volunteers aged 18 to 50 years. Study design is a double-blind, randomized, crossover study of the comparative pharmacokinetics of drugs. The drugs were injected subcutaneously into the anterior abdominal wall at a dose of 0.4 IU / kg once. The duration of blood sampling to determine the pharmacokinetic parameters was 24 hours: the concentration of insulin in the blood was determined by enzyme-linked immunosorbent assay. Based on the level of glycemia, the glucose infusion rate was adjusted, the data of which were used to calculate the pharmacodynamic parameters. Results and discussion. Comparability of the main pharmacokinetic and pharmacodynamic characteristics of the Rinsulin® mix 30/70 and Humulin® M3 preparations in the conditions of hyperinsulinemic euglycemic clamp in healthy volunteers was noted. The confidence interval for the logarithmically transformed ratio of the values of the parameter C_ins.max was 87.31-105.26%, and AuC_ins.0-12 - 85.23-110.90%, which falls within the limits set by regulatory documents 80-125% to establish comparability between drugs. This confirms the high similarity of the reproduced Rinsulin® Mix 30/70 to the original drug. Of particular clinical significance is the synchronous onset of drug action, the time of onset of the maximum effect and duration of action. Adverse events in the study associated with the introduction of drugs were not recorded. Conclusions. Rinsulin® mix 30/70 and Humulin® M3 are equivalent.

Justification. On average, about 12 % of all global healthcare spending on diabetes. One of the first domestic human insulin preparations was Rinsulin® R, the biosimilar (bioanalog) of Humulin® Regular. The clinical research program for biosimilars of insulin preparations includes pharmacology studies: pharmacokinetics, pharmacodynamics and clinical safety research. Purpose. Evaluation of the biosimilarity of the Rinsulin® R (biosimilar) and Humulin® Regular (original) preparations in the conditions of hyperinsulinemic euglycemic clamp in healthy volunteers. Materials and methods. The study was conducted on healthy male volunteers aged 18 to 50 years. Study design is a double-blind, randomized, cross-sectional study of comparative pharmacokinetics and pharmacodynamics of drugs. The drugs were injected subcutaneously into the anterior abdominal wall at a dose of 0.3 IU / kg once. The duration of blood sampling to determine the pharmacokinetic parameters was 10 hours: the concentration of insulin in the blood was determined by enzyme-linked immunosorbent assay. Based on the level of glycemia, the glucose infusion rate was adjusted, the data of which were used to calculate the pharmacodynamic parameters. Results and discussion. It was found that the studied drugs are characterized by a high degree of similarity of pharmacokinetics and pharmacodynamics. 90 % confidence intervals for the ratios of the geometric mean values of the primary pharmacokinetics AUC_ins.0-t and C_ins.max fully correspond to the permissible limits of 80-125 % and are, respectively, 88.61-111.52 and 85.411-109,51 %. 95 % confidence intervals for the ratios of the geometric mean values of the primary pharmacodynamics AUC_GIR0-t and GIR_max fully correspond to the permissible limits of 80-125 % and are, respectively, 93.48-112.29 and 95.75-109.17 %. Of particular clinical significance are the synchronous onset of action of drugs, the time of onset of the maximum effect and duration of action. The frequency of adverse events was comparable in the drug groups. Conclusions. Rinsulin® R and Humulin® Regular are equivalent.