Peculiarities of functioning and polymorphism of cytochrome P450 isoenzyme CYP2D6. Existing methods for determining its activity using endogenous markers. A review of studies on the screening of endogenous substrates, biotransformation mainly under the influence of isoenzyme CYP2D6. The results by determination pinoline relationship to its metabolite 6-hydroxy-1,2,3,4-tetrahydro-beta-carboline in vitro in cell culture and in vivo in mice for evaluation isoenzyme activity CYP2D6.

The article describes the basic terms and definitions relating to biosimilars, generics and original drugs. Also described a brief history of the origin and development of the biotechnology industry and drugs produced using biological objects. The main difference between biosimilars and generics, as well as their differences to innovative medicines. The process of biotechnological production, and main applications of biosimilars. It analyzed the legal framework of the Russian Federation and the European Union.

The article deals with the modern requirements to the quality of the allergenic extracts used for allergen-specific immunotherapy. The comparative analysis of regulatory documents governing the quality of the allergenic drugs. Presents the requirements of the European Pharmacopoeia the quality of allergens like pharmaceuticals. The possibilities of application of modern physico-chemical methods (HPLC-MS, NMR) analysis of drugs in this group.

Within the cross, a single, open, randomized study with a week washout period, the two sequences has been studied bioequivalence of tablet forms two ondansetron 18 volunteers (8 mg dosage). Plasma samples were analyzed by a validated HPLC-MS, tropisetron was used as the internal standard. Limit of quantification was 1 ng/ml. Analyzed for drugs following pharmacokinetic parameters were calculated: AUC_0-t, C_max, T_max, MRT, C_max/AUC ' 90% confidence interval for log-transformed values of AUC_0-t was 0,9507 - 1,0037, of AUC_{(0-∞ )}. was 0,9402-0,9974, of C was 0,9255 - 1,0095. The study concluded that bioequivalence compared ondansetron drugs.

In a single-dose, two-treatment, two-period, two-sequence crossover study with a 1-month washout period was carry out the bioequivalence study of two tablet coated formulation of carbamazepine that given to 18 volunteers in equal doses (400 mg). Drug blood plasma concentrations were determined by validated LC-UV method for 120 hours. There were calculated the followed parameters: AUC_0-t, C_max , T_max, C_max /AUC. 90% confidence interval for log-transformed AUC. values was 0,93693 - 1,10204 and one for log-transformed C_max was 0,91045 - 1,12287, respectively. It was made the conclusion about bioequivalence of compared carbamazepine formulations.

In a single-dose, two-treatment, two-period, two-sequence crossover study with a 1-week washout period was carry out the bioequivalence study of two tablet coated formulation of fosinopril that given to 18 volunteers in equal doses (20 mg). Drug blood plasma concentrations were determined by validated LC-MS method for 48 hours. There were calculated the followed parameters: AUC _0-t ,C_max, t_max , C_max /AUC. 90% confidence interval for log-transformed AUC _0-tvalues was 0,9393 - 1,1473 and one for log-transformed C_max was 0,8861 - 1,066, respectively. It was made the conclusion about bioequivalence of compared fosinopril formulations.

The effect of single and multiple modes of administration pantogam (pantokaltsina) and bemitil (metaprot) on the dynamics of nootropic specific and nonspecific behavioral effects of anxiolytic drugs and their possible association with NMDA- and benzodiazepine receptors in the brain of inbred C57BL/6 and BALB/c. The line BALB/c is characterized by decreased compared to mice C57BL/6 baseline levels of cognitive and emotional status, NMDA- and benzodiazepine receptors in the hippocampus and the prefrontal cortex, and therefore has been used as a non-invasive model of deficit manifestations of these functions. Under the influence of acute, 7- and 14-fold administration pantogam (200 mg/kg/day intraperitoneally) in BALB/c mice was observed slow increase in NMDA-receptors and slow rise specific effect characteristic nootropics. Anxiolytic effect of the drug in mice BALB/c and C57Bl/6 was not detected, however, the line C57Bl/6 showed an increase in the density of benzodiazepine receptor in the first week and by the end of the experiment density reduction below the control was observed in both lines. Under the influence of acute, 7- and 14-fold bemitil administration (25 mg/kg/day intraperitoneally) in BALB / c mice at an early stage of the experiment there was a rapid increase in NMDA-receptors and efficiency of exploratory behavior, disappearing in the following days. The observed dynamics quickly realized most likely is not unique nootropic and psychoactive component of the pharmacological effect of the drug. Anxiolytic effect developed during the first week indiscriminately for both lines, however, decrease benzodiazepine reception detected at day 14 in both lines.

The paper presents the results of experimental studies of pharmacokinetics GB-115 after oral administration of crystalline and micronized substances and 4 new laboratory samples pharmaceutical compositions which differ in the technology of preparation and composition of excipients. It is shown that different excipients and preparation technology significantly affect the pharmacokinetics and effect of studied dipeptide; its optimization is improve the pharmacokinetics properties of the developed compound, namely increasing completeness of absorption, maximum concentration, rate and extent of absorption in the final result in bioavailability GB-115. On the basis of experimental data obtained two pharmaceutical compositions recommended for further pharmacological study.