Providing the population of Ukraine with quality, effective and, at the same time, economically affordable medicines is a priority task of the healthcare system. Taking into account the relatively low cost of their development generic drugs are available to the majority of the country’s population; thus, bioequivalence studies are needed to obtain data on their efficacy and safety. Ukraine is currently in the process of harmonizing domestic regulatory requirements for generic drugs and conducting bioequivalence studies with global ones. Therefore, it is important to find out the differences in approaches to the registration of generics and studies of their bioequivalence in Ukraine and other countries. Another important aspect is to provide the policy of “transparency” of bioequivalence research results, which contributes to the use of better drugs. Aim. To analyze domestic and global approaches to the organization of the bioequivalence research and provide the policy of “transparency” of their results. Materials and methods. A comparative analysis of approaches to drug registration, requirements for generic drugs and bioequivalence studies and ways to provide the policy of “transparency” of their results in Ukraine, the United States and the European Union was conducted. Results. The analysis has revealed that the methods of registration of drugs in Ukraine, the United States and the EU are the same. Approaches to providing the “transparency” of the results of bioequivalence studies differ since in Ukraine the publication of such information is not mandatory and is at the discretion of pharmaceutical manufacturers. Conclusions. Domestic regulatory requirements for assessing generic drugs are harmonized with the world ones. Today, there is a need to introduce a mandatory requirement for the publication of bioequivalence studies, and it will contribute to providing an effective “transparency” policy.

Apoptosis is the main mechanism of chondrocytes death in osteoarthritis. Unlike necrosis, it is characterized as a process by which a cell itself actively initiates and causes its destruction. The following morphological and biochemical properties are characteristic for apoptosis: chromatin condensation and DNA fragmentation; the appearance of specific markers on the cell surface; cell shedding and the loss of contact with neighboring cells and the matrix; the nuclear membrane change; vacuolization and formation of apoptotic bodies. In the articular cartilage apoptosis occurs in response to compression, mechanical damage, disruption of trophism, or experimental influence.Aim. To study the effect of the combination containing doxycycline and glucosamine on chondrocytes apoptosis processes on the model of systemic steroid arthrosis in rats compared to its active monocomponents – doxycycline and glucosamine.Materials and methods. The therapeutic properties of the combination on the model of systemic steroid arthritis caused by dexamethasone were studied in-depth. It was reproduced by the intramuscular injection of dexamethasone phosphate three times in the dose of 7 mg/kg with an interval of one week with elements of modification consisted in increasing the dose of glucocorticosteroid. To assess apoptosis in an articular cartilage the TUNEL method was used.Results. As a result of the morphometric studies a significant decrease in the number of TUNEL-positive apoptotic cells was observed under the influence of all the objects studied compared to the control pathology rats. It was also found that the combination studied had significant differences by this indicator compared to other experimental groups. Dexamethasone administration was shown to cause a proapoptotic effect. The composition has a protective effect on chondrocytes, balancing the processes of catabolism and anabolism of cellular homeostasis in them.Conclusions. According to the results of the studies conducted the combination containing doxycycline and glucosamine can be assessed as an agent with a high chondroprotective activity; it is promising for further use in patients with destructive joint diseases, in particular osteoarthritis.

In recent years, the system of cytokines has a significant role in forming and progressing chronic heart failure of various etiologies (ischemic, inflammatory, infectious and allergic, etc.). Aim. To study the activity of proinflammatory cytokines (interleukin-1α (Il-1α), interleukin-1β (Il-1β), interleukin-6 (Il-6) and interleukin-8 (Il-8) and anti-inflammatory cytokine (interleukin-4 (Il-4) in heart failure (HF) in thyrotoxicosis patients.Materials and methods. 64 patients and 20 healthy volunteers were examined; they were distributed in 3 groups: group I (44 patients) patients with thyroid cardiomyopathy, group II (20) patients with no sign of cardiomyopathy and group III – 20 healthy volunteers. The serum levels of interleukines 1α, 1β, 4, 6 and 8 at admission, in 21 days and 6 months were measured.Results. The level of IL-6 and IL-8 were significantly higher in patients with thyrotoxic HF compared to those without HF and healthy subjects. Correlation in Il-6 and Il-8 serum levels and severity and duration of HF were revealed. No correlation in Il-4 serum levels and HF was found.Conclusions. It can be assumed that Il-6 and Il-8 are involved in the progression of heart failure and, less likely, in the formation of cardiomyopathy; however, for a more accurate identification of these regularities further studies are required.

In the model of collagen-induced arthritis in rats studied anti-inflammatory properties of compositions based on a combination of doxycycline hydrochloride and glucosamine hydrochloride in comparative aspect with its active monokomponentamy - doxycycline, glucosamine hydrochloride. As a result of experimental studies demonstrated that a composition based on a combination of doxycycline hydrochloride and glucosamine hydrochloride, exhibits a pronounced beneficial effect on indicators of exchange cartilage and bone on the background of autoimmune arthritis and leads to inhibition of immunoinflammatory processes in the connective tissue of animals. The noted normalization of the functional state of the joints and clinical and biochemical parameters. The degree of pharmacological effect on most studied parameters combination (D+HA) exceeds a reference facility - the substance doxycycline hydrochloride and glucosamine. Composition (D+HA) is a promising proof-inflammatory and destructive joint disease with an autoimmune component and can be recommended for use in complex therapy of patients with inflammatory and immune-inflammatory-destructive diseases of the joints.

The article presents the results of the experimental study of the acute toxicity of tetracyclines. The tasks of this study were to conduct the comparative analysis of safety as well as finding the median lethal dose (LD50) of tetracycline hydrochloride, doxycycline hydrochloride, methacycline hydrochloride and to determine the optimal remedy for the further studies as anti-inflammatory and chondroprotective drug. It has been found that the LD50 of tetracycline hydrochloride after single oral administration in rats is 1478.22±201.67 mg/kg, LD50 of doxycycline hydrochloride – 1893.03±286.20 mg/kg and LD50 of methacycline hydrochloride – 1635.73±199.36 mg/kg. Thus, doxycycline is significantly safer than tetracycline and methacycline.