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THE INTERNAL AUDITORS OF PHARMACEUTICAL QUALITY SYSTEMS COMPETENCE IMPROVING
Get PDFThe importance of internal audits for the pharmaceutical company, which is indicated in the guidelines for good practices in pharmacy (in particular, GMP, GDP).
The issue of selection, training, grading, certification and continuous improvement of the auditor’s competence at pharmaceutical companies are relevant and important both for domestic ones, and for foreign enterprises.
The aim of the study was to determine the competence of the pharmacy quality system internal auditors’ and the areas of its development.
Materials and methods. The object of the study was the competence of internal auditors of pharmaceutical quality systems. Empirical and theoretical research methods were used, in particular the method of comparative analysis of scientific literature in the field of research, the method of structural and logical modeling. The information basis was the provisions of regulations and materials published in the open professional scientific literature.
Results. The competence of quality management system auditors in general and pharmaceutical quality system in particular consists of personal qualities, professional knowledge and skills. The ISO 19011 standard highlights the importance of evaluating and continuous development of auditors’ competence. Such an assessment should take into account the needs of the audit program and its objectives. Areas of development of auditors' competence should be determined by the specifics of industry activities. This provision of the standard should be considered relevant for pharmaceutical companies.
Conclusions. We studied the requirements for the competence of QMS internal auditors of international and industry standards. A review of the regulatory framework showed a lack of information on the chosen area of the research. Defined requirements for the competence of the PQM audits staff assists the selection of specialists to the audit team so that the overall competence of the audit team is sufficient to achieve the objectives of the audit
The levels of relaxin and amino acids play a critical role in women with variable degree of preparedness for labour
Get PDFUnderlying biochemical factors that contribute towards the preparedness for labour and ripening of the cervix remain largely unknown. We aimed to characterize metabolic and hormonal determinants that constitute the preparedness for labour in women.
The aim of the research was to study the content of relaxin and amino acids involved in its formation in primiparous pregnant women with various degrees of birth preparedness.
Materials and methods: Prospective study has been conducted on 115 primiparous women at 38-40 weeks of gestation. Biochemical methods were used to analyse relaxin and amino acid levels in pregnant women with varying degree of birth preparedness. Results: the obtained data from the study indicate importance role of relaxin in the underlying pathogenesis in women with variable degree of preparedness for labour. The results allow to use the levels of relaxin serum as a predictor of the state of the birth canal. Furthermore, the amino acids are known to participate in various critical metabolic processes and play an important role is orchestrating many essential pathways in the body. We present the analysis of amino acids involved in the formation of relaxin in the serum of pregnant women. Our analysis has shown that amino acid imbalance leads to disruption of energy metabolism and blood flow rate, resulting in metabolic, structural and functional changes in the cervix at the onset of labour. Conclusion: considering the mechanisms of the possible influence of relaxin and amino acids on the cervical ripening, we concluded that correcting amino acid imbalance and normalising relaxin levels should be included in preinduction of labour therapeutic regimen. This would be an important step in improving the perinatal outcome
Monitoring of Salmonella infection of poultry for the period from 2016 to 2020
Get PDFSalmonellosis is an acute intestinal infectious disease that belongs to the group of zoonoses that cause acute toxic infections in humans through the consumption of products of animal or plant origin contaminated with bacteria of the genus Salmonella spp. Salmonellosis is registered in all countries of the world, and our state is no exception.
The aim of the research. Monitor salmonellosis pathogens in Ukrainian poultry farms and, on the basis of the obtained data, establish the relationship between avian and human diseases for salmonellosis.
Materials and methods. The research was conducted in poultry farms in the North-Eastern region of Ukraine. Test systems from R-biopharm-Compact Dry SL and RIDA®STAMP SL were used for rapid diagnosis of bacterial microflora. To establish the salmonella serotype, the Spectate® salmonella test system was used, which is based on the use of latex strips coated with special antibodies to the corresponding serogroups of Salmonella A, B, C, D. Microbiological examination was performed washing from the walls, floor, eggshell, Brooder's cabinets and pathogens heart, liver, gallbladder of the dead bird. The relationship between isolated salmonella serovars from poultry was compared with salmonella isolated from humans according to the reporting form No. 40 “Zdorov”.
Results. Various salmonella serovars were isolated from experimental farms of Ukraine, namely:
Serovars such as S. Gallinarum–pullorum – 7.9 %, S. Enteritidis – 6.5 % were isolated from the meat and egg direction. From the meat direction, the following are: S. Tiphimurium – 12.5 %, S. Arizona – 6.0 %, S. Enteritidis – 3.5 %. From the breeding direction were also isolated from adult birds and hatching eggs in large quantities – S. Gallinarum–pullorum – 19.0 %, S. Tiphimurium – 17.8 %, S. Enteritidis – 10.1 %.
The following species were separately isolated from the premises of the same farms in percentage terms: S. London – 1.7 %, S. Infantis – 1.5 % S. Bredeney – 1.4 %, S. Tsioque – 1.4 %, S Jawa – 1.2 %, S. Montevideo – 1.1 %, and 1 % each isolated S. Kentyki, S. Abony and S. Oxford. Pathogens of paratyphoid diseases were isolated from poultry and poultry products (S. Gallinarum–pullorum, S. Enteritidis, S. Tiphimurium) for the entire study period from 2016 to 2020 inclusive.
Comparing the obtained data from state institutions of humane medicine, it should be noted that there was a tendency for the spread of salmonellosis among people associated with the consumption of poultry products.
Conclusions. The obtained results indicate that salmonella infection is quite common among a number of poultry farms of different technological direction. In particular, bacteria of the genus Salmonella were isolated from meat, eggs and birds of different ages from the studied poultry houses in the North-Eastern region of Ukraine.
As a result of monitoring of salmonellosis in Ukraine over the past five years, fluctuations in the incidence of salmonellosis among people ranged from a maximum of 74 % (2018) to a minimum of 30.1 % (2020), and for two years, there has been a reduction in cases due to the introduction of new international requirements and standards for product quality control at all stages of production of the Hazard Analysis and Critical Control Point (HACCP) system
The effect of the drug "Cobazin" on the productive indicators of bee colonies
Get PDFThe aim of the study was to determine the effectiveness of the drug "Cobazin" on the productivity of bee colonies during the increase in strength (increase in the number of young bees in the bee colony) in spring and autumn.
Materials and methods. Control and experimental groups were formed to test "Cobazin" feed supplement. It was fed 5 times with an interval of 5 days. Bee colonies from the control group received a pure sugar solution (1:1) in the amount of 0.5 liters per bee colony, and the experimental group received a sugar solution of 0.5 liters per bee colony (1:1) with the addition of the drug "Cobazin" in the amount of 2.5 g.
Indicators characterizing the development of bee colonies were determined by a measuring frame of 5x5 cm in size, for 12 days to cover the total number of eggs laid by the queen bee during feeding. Four measurements were performed during the study. The results of the control and experimental groups were compared and the significance of the differences between them was established. There was a comparison of the difference between groups of bees both fed pure sugar syrup in a ratio of 1:1 and syrup with the addition of the drug "Cobazin".
Results. It is proved that during the feeding period the number of brood in bee colonies that received feed supplement "Cobazin" increased significantly by 76 % (71 % in the group that received only sugar solution without this drug). Live weight of queen bees in colonies that were stimulated with "Cobazin" was actually 2 % higher compared to the control group.
It was found that at the end of the bee season, bee colonies fed in May with the feed supplement "Cobazin" had significantly higher values of strength, number of sealed brood and live queen bees compared to those who received pure sugar solution. The brood in the control group was 25 % lower than in the experimental group.
Conclusions. For the first time it was proved that the use of feed supplement "Cobazin" in combination with sugar solution has a positive effect on the features that characterize the development of bee colonies (strength, number of sealed brood) and their health productivity. The positive impact is observed not only during feeding, but also in subsequent periods of colony development
The importance of compression sonoelastography in improving the diagnostics of the pathology of myometrium
Get PDFThe diversity of the clinical picture and the asymptomatic nature of the clinical manifestations of myometrial pathology cause difficulties in diagnosis. There is a lack of reliable diagnostic criteria for this pathology, in particular, imaging, especially with the simultaneous combination of adenomyosis and leiomyoma.
The aim of the research. Determination of the possibility of compression sonoelastography in the diagnosis of myometrial pathology and determination of its sonoelastography characteristics in leiomyoma and adenomyosis, as well as comparison of sonoelastography results with histological data.
Materials and methods. Elastography images of 155 patients with adenomyosis and leiomyoma, as well as combined pathology, were analyzed, the elastography diagnosis of which was confirmed by histological examination.
Results. Leiomyoma and adenomyosis had different elastography characteristics (strain ratios) with different color mapping; their specific characteristics and main differences are determined. Based on sonoelastography, the majority of patients (n=30) were suspected of having uterine fibroids, 14 had adenomyosis, and 42 had adenomyosis and fibroids. Sonoelastography revealed histological signs of adenomyosis in 3 patients with uterine leiomyoma.
Conclusions. Ultrasound examination using compression sonoelastography in such pathological conditions of the myometrium as adenomyosis and leiomyoma, as well as unchanged myometrium, makes it possible to determine changes in the degree of elasticity of the myometrium in the corresponding pathology. Sonoelastography allows the identification of clear distinguishing features of fibroids and adenomyosis. The unchanged myometrium has a certain elasticity, which can be equated to a specific numerical value – the coefficient of deformation. This indicator has different meanings in myoma and adenomyosis, which makes it possible to differentiate these pathological conditions of the myometrium. Compression sonoelastography is able to identify clear distinguishing features of leiomyoma and adenomyosis, and consistency of diagnoses based on sonoelastography and histology is significant but not optimal.The diversity of the clinical picture and the asymptomatic nature of the clinical manifestations of myometrial pathology cause difficulties in diagnosis. There is a lack of reliable diagnostic criteria for this pathology, in particular, imaging, especially with the simultaneous combination of adenomyosis and leiomyoma.
The aim of the research. Determination of the possibility of compression sonoelastography in the diagnosis of myometrial pathology and determination of its sonoelastography characteristics in leiomyoma and adenomyosis, as well as comparison of sonoelastography results with histological data.
Materials and methods. Elastography images of 155 patients with adenomyosis and leiomyoma, as well as combined pathology, were analyzed, the elastography diagnosis of which was confirmed by histological examination.
Results. Leiomyoma and adenomyosis had different elastography characteristics (strain ratios) with different color mapping; their specific characteristics and main differences are determined. Based on sonoelastography, the majority of patients (n=30) were suspected of having uterine fibroids, 14 had adenomyosis, and 42 had adenomyosis and fibroids. Sonoelastography revealed histological signs of adenomyosis in 3 patients with uterine leiomyoma.
Conclusions. Ultrasound examination using compression sonoelastography in such pathological conditions of the myometrium as adenomyosis and leiomyoma, as well as unchanged myometrium, makes it possible to determine changes in the degree of elasticity of the myometrium in the corresponding pathology. Sonoelastography allows the identification of clear distinguishing features of fibroids and adenomyosis. The unchanged myometrium has a certain elasticity, which can be equated to a specific numerical value – the coefficient of deformation. This indicator has different meanings in myoma and adenomyosis, which makes it possible to differentiate these pathological conditions of the myometrium. Compression sonoelastography is able to identify clear distinguishing features of leiomyoma and adenomyosis, and consistency of diagnoses based on sonoelastography and histology is significant but not optimal
Directions for improving adaptive management efficiency of manufacturing pharmaceutical companies
Get PDFThe aim of the article is to analyze the existing problems of adaptive management of manufacturing pharmaceutical companies and the development of methodological support for their management.
Materials and methods. The research used methods of theoretical generalization, analysis and synthesis, synergetic approach and expert survey.
120 people were involved in the expert survey, divided into four groups: representatives of pharmaceutical manufacturing enterprises (30 people); representatives of pharmaceutical higher education institutions (30 people); pharmaceutical distributors representing wholesale companies (30 people); end users (30 people).
Results. The article considers scientific and methodological approaches to improving adaptive management in the direction of forming competitive advantages of manufacturing pharmaceutical companies, the practical implementation of which requires business entities determination, flexibility and adequacy in the formation of modern management strategies and tactical planning and operational tasks of production, economic and commercial activities. There are external and internal factors influencing the formation of competitive advantages of the business entity. As the internal factors we include: organizational and legal form, and business entity organizational structure; the level of scientific and technical development of production; level of education and qualification of staff; business image of the enterprise; financial reputation of the enterprise. However, no less influence on the formation of competitive advantages of the management of manufacturing pharmaceutical companies have external factors, which, in contrast to internal, are not controlled by the entity: the state of the pharmaceutical market; technologies; workforce; scientific and technical development; etc.
Conclusions. The directions of increasing the adaptive management efficiency are determined and it is concluded that the main criterion of efficiency is the quality of pharmaceutical products and the quality of management decisions in economic risks
CORRELATION ANALYSIS OF GSTP1 GENE POLYMORPHISM WITH MORBIDITY OF PRIMARY METASTATIC COLORECTAL CANCER
Get PDFColorectal cancer (CRC) is one of the most common malignancies. Susceptibility to malignant processes is mediated by genetically driven differences in the effectiveness of detoxification of potential carcinogens. One of the factors that may influence the risk of CRC is the glutathione-S-transferase (GST) gene family that encodes glutathione transferase enzymes. The GSTP1 gene is expressed both in normal and pathological conditions. Determining its specific alleles may be a marker of CRC.
The aim of the research – to study GSTP1 gene polymorphism, which is likely to be more common among patients with primary metastatic colorectal cancer compared with healthy population.
Materials and methods. The study involved 12 patients with primary metastatic colorectal cancer aged 43 to 72 years, the control group was represented by a sample of 31 people without cancer.
Results. The incidence of advanced CRC in the presence of GSPT1 Val / Val (aa) polymorphism is statistically significantly higher than in the presence of Ile / Ile (AA) and Ile / Val (Aa) GSPT1 polymorphism.
Conclusions. Among people with GSTP1 Val / Val (aa) polymorphism, primary CRC is 4.4 times more likely than among people with GSPT1 Ile / Ile (AA) and Ile / Val (Aa) polymorphisms, which are statistically significant (P < 0.05). The obtained results indicate the possibility of conducting a genetic study of GSTP1 polymorphism to form groups of potential risk of CRC
DETERMINATION OF OPTIMAL EXTRACTION CONDITIONS OF PHENOLIC COMPOUNDS FROM ACORUS CALAMUS LEAVES
Get PDFFrom the beginning of its existence and until now, interest in herbal remedies has only grown. Not surprisingly, medicinal herbs are a source of unique combinations of biologically active components that are capable of exhibiting significant pharmacological effects. One of these medicinal plants is Acorus calamus (sweet flag), whose rhizomes have long been used in official and folk medicine, cooking and cosmetology. However, recent studies point to the considerable potential of the aerial part of Acorus calamus as a novel herbal remedy, which is associated with the presence in the leaf of the plant, in addition to essential oil, a considerable amount of substances of phenolic nature.
The aim of the research was to determine the optimal conditions for the removal of phenolic compounds from the leaves of Acorus calamus and to determine the technological parameters of raw materials.
Materials and methods. During the research, samples of raw materials collected on the territory of Kharkiv region were used, as well as methods that are given in the State Pharmacopoeia of Ukraine.
Result. As a result of the research, the extraction conditions at which there was highest content of the extraction of biologically active substances were determined. The extractant, the degree of grinding of the raw material and the optimum extraction time were selected, which allowed to extract almost 80 % of the quantitative content of flavonoids from the raw material. The main technological parameters of Acorus calamus leaves were also determined. The obtained results will be the basis for the development of the technology of obtaining phyto-substance from the leaves of Acorus calamus.
Conclusions. The selection of optimal extraction conditions of biologically active compounds from Acorus calamus leaves was carried out. The obtained results show that in order to obtain extracts with the maximum content of biologically active substances (flavonoids), it is advisable to use raw materials with a particle size of 0.5 to 1.0 mm, as an extractant 70 % alcohol and an extraction time of 4 hours
DEVELOPMENT OF THE EMULGE LFOR THE ANDROGENIC ALOPECIA TREATMENT
Get PDFAndrogenic alopecia (AGA) is the most common alopecia that is heritable, androgen-dependent and occurs in both sexes with defined patterns such as Male pattern hair loss in men and Female pattern hair loss in women. AGA affects at least 50 % of men by the age of 50 years, and up to 70 % of all males in later life.
The aim.The research was aimed to substantiate the optimal concentration of excipients and active pharmaceutical ingredients (APIs) of the emulgel intended for the topical treatment of androgenic alopecia.
Materials and methods. In this study the samples of the emulgel bases containing different carbomer Ultrez10 concentrationsin the range of 0.3–0.6 % and its neutralizers (0.1 % of potassium sorbate and 0 % or 0.2 % of triethanolamine) were used. Colloidal and thermal stability, pH, rheological properties (structural viscosity, mechanical stability, degree of thixotropy) of these samples were determined. The emulgel samples with different percentages of the Serenoa repens dry extract and the Sophora japonica tincture were used in the biopharmaceutical studies. The samples of the emulgel with the antioxidant butylhydroxytoluene different concentrations (0 %, 0.01 %, 0.02 %, 0.03 %) were used to determine acid value during 1 year of the emulgel storage.
Results and discussion. It was experimentally substantiated the optimal ratio of the emulgel ingredients that provide good APIs release and necessary consumer properties of the semi-solid remedy like application compliance, safety and storage stability.
Conclusions. Physicochemical, rheological and biopharmaceutical properties of emulgel bases have been studied. It was found that the base №2 (in which the concentrations of Carbomer Ultraz 10, potassium sorbate and triethanolamine are 0.3 %, 0.1 %, 0.2 % respectively) possessed the optimal properties. Considering the results of the complete range of experimental research it was developed the final formulation of the emulgel intended for AGA treatment which included the concentration of the APIs, neutralizers, preservatives, antioxidant and fragrance
DEVELOPMENT OF PRIMARY OPEN-ANGLE GLAUCOMA AND DELETION POLYMORPHISM OF THE GLUTATHIONE-S-TRANSFERASE GENES
Get PDFThe aim of the research. To investigate the association of the development of primary open-angle glaucoma with deletion polymorphism of glutathione-S-transferase genes.
Materials and methods. Under our observation there were 172 patients, residents of Ukraine with primary open-angle glaucoma I–IV stages. Analysis of the deletion polymorphism of GSTM1 and GSTT1 genes was performed by real-time polymerase chain reaction using unified TaqMan Mutation Detection Assays Life-Technology (USA) test systems. Statistical analysis of the obtained data was performed using the MedStat package and the statistical package MedCalc v.15.1 (MedCalc Software bvba).
Results and discussion. The detection of null alleles of the GSTM1 gene was observed in 39 % of patients in the control group, in patients with POAG a significant increase in the frequency of deletion polymorphism to 50–56 % was observed with the progression of the disease in stages II-IV. In patients with stage IV disease, the effect of the zero GSTM1- null allele on POAG course was determined (χ2=3.97; p=0.047), and the null allele of GSTM1 doubled the probability of developing the disease (OR=2.01; 95 % CI=1.01–4.01) in patients of group 4 compared with control. The null allele of the GSTT1 gene in the control group was found in 31 %, an increase in the frequency of the GSTT1-null allele was also observed in the second and fourth stages of POAG from 41 % to 54 %. Statistically significant differences of GSTT1 gene allele frequencies were determined between the control group and all patients with POAG (χ2=4.43; p=0.03), between the control and the 4th group (χ2=7.64; p=0.01), and between the 1st and 4th groups (χ2=5.52; p=0.02). An association with the development of POAG (χ2=4.43; p=0.03) was determined for the deletion polymorphism of the GSTT1 gene when comparing the control group with the data of all patients with POAG (1–4 groups). At stratification by stages of POAG (that is, by groups of patients), an association with the development of POAG was determined only in patients of group 4 (χ2=7.64; p=0.01) compared with the control group.
Conclusions. The association of the null allele of the GSTT1 gene with POAG was established (p=0.03). The presence of the GSTT1-null allele significantly increased the risk of developing POAG (OR=1.75; BI=1.04–2.96) compared with the control group. The presence of null alleles (GSTM1-null and GSTT1-null) of the GST deletion polymorphism significantly increased the risk of stage IV POAG (OR=2.01; BI=1.01–4.01 and OR=2.66; VI=1.32–5.37, respectively) compared with the control group, which indicated the effect of zero alleles on the rapid progression of the disease