718 research outputs found

    Use of accelerated helium-3 ions for determining oxygen and carbon impurities in some pure materials

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    Methods are developed for the determination of O impurity in Be and Si carbide and concurrent determination of C and O impurities in Si and W by irradiation with accelerated He-3 ions and subsequent activity measurements of C-11 and F-18 formed from C and O with the aid of a gamma-gamma coincidence spectrometer. Techniques for determining O in Ge and Ga arsenide with radiochemical separation of F-18 are also described

    Study of the dynamic structure of the near-lunar orbital space

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    The knowledge of the dynamic features of the near-lunar space is necessary for its optimal mastering. This work is devoted to a study of the special features of the dynamics of the artificial Moon satellites (AMS) with intermediate and high orbits in the range of semimajor axes from 2500 to 26000 km

    Distributed teams: challenges and opportunities

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    A  geographically dispersed workforce poses new challenges for managers, which shift the focus from project management to managing distributed project teams. Adapting the company and its management to this evolution in the workplace, it is necessary to create an  environment in which remote team members interact productively. Distributed work requires operational flexibility from companies, which is characterised by  greater susceptibility to changes in their markets, to new emerging customer requirements and new competitive threats. The article is devoted to the identification of factors contributing to the transition of companies to the distributed workforce, the advantages of this type of work, and the difficulties that companies will face

    Bempedoic Acid: Safety and Efficiacy of a New Lipid-Lowering Agent

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    Scientific relevance. Lowering low-density lipoprotein cholesterol (LDL-C) levels with statins is a generally accepted standard treatment for dyslipidaemia. However, adverse reactions and intolerance to statins have motivated the search for lipid-modifying agents with alternative mechanisms of action. Bempedoic acid is one of these alternative agents.Aim. The study aimed to review published data on the mechanism of action, pharmacokinetics, pharmacodynamics, safety and efficacy of bempedoic acid used as a lipid-lowering agent.Discussion. Similar to statins, bempedoic acid inhibits cholesterol synthesis from acetyl-CoA. Statins and bempedoic acid differ in their mechanisms of action mainly because the conversion of bempedoic acid into its active metabolite takes place only in the liver. As a result, bempedoic acid does not cause adverse drug reactions in muscles. The main safety and efficacy data on bempedoic acid were obtained in phase III CLEAR trials. Compared to placebo, bempedoic acid reduced LDL-C levels by an additional 18% in combination with maximum tolerated doses of statins and by 25% in monotherapy in patients with statin intolerance. In the CLEAR Outcomes trial, long-term treatment with bempedoic acid reduced the risk of major adverse cardiovascular events in patients with statin intolerance (n=13970) by 13%. A slight increase in gout attack frequency was observed, primarily in patients with pre-existing hyperuricaemia.Conclusions. Therefore, bempedoic acid is a safe and effective treatment option for patients with dyslipidaemia at high risk of atherosclerotic cardiovascular disease. It can be used either in combination with statins or, in the case of statin intolerance, as monotherapy and with ezetimibe

    Using Shewhart charts to monitor quality characteristics of preventive vaccines for tuberculosis

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    Scientific relevance. The quality of medicinal products, particularly vaccines, is contingent on the stability of the manufacturing process at all stages, which can be evaluated using Shewhart charts for data obtained by monitoring the quality attributes of interest.Aim. This study evaluated the stability of the quality and manufacturing processes of the BCG and BCG-M tuberculosis vaccines using Shewhart charts.Materials and methods. This study focused on samples of the BCG tuberculosis vaccine and the BCG-M tuberculosis vaccine, a less reactogenic alternative for primary immunisation. Both vaccines were released to the market in 2019–2022. The quality of samples was assessed for stability based on their potency and total bacterial count, which are the key parameters for immunogenicity evaluation. These quality parameters were compared using test results submitted by the manufacturer and obtained at the testing centre. The authors plotted individuals charts (X-charts) and moving range charts (R-charts) in accordance with national standards GOST R 50779.42-99 and GOST R ISO 7870-2-2015.Results. The quality of the BCG and BCG-M vaccines remained stable during the entire follow-up period (2019–2022). For some periods, the retrospective analysis of R- and X-charts revealed characteristic trends meeting special cause criteria. The Pearson correlation coefficient (r) between the data submitted by the manufacturer and the data obtained at the testing centre ranged from 0.2 to 0.8.Conclusions. The Shewhart charts demonstrated that the quality parameters of the BCG and BCG-M tuberculosis vaccines tested in 2019–2022 were stable. These vaccines had stable manufacturing processes, as shown by the R- and X-charts. However, the warning signs indicated that additional measures should be taken to standardise the manufacturing processes. The findings suggest that Shewhart charts may be recommended for monitoring the production and quality of tuberculosis vaccines
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