This multicentre, open-label, prospective, single-arm study was designed to evaluate the efficacy, pharmacokinetics, and safety of IqYmune®, a highly purified 10% polyvalent immunoglobulin preparation for intravenous administration in patients with primary immunodeficiency. IqYmune® was administered to 62 patients (aged 2–61 years) with X-linked agammaglobulinemia or common variable immune deficiency at a dose from 0.22 to 0.97 g/kg every 3 to 4 weeks for 12 months with an infusion rate up to 8 mL/kg/h. A pharmacokinetic study was performed at steady state between the 8th and the 9th infusion. A single case of serious bacterial infection was observed, leading to an annualized rate of serious bacterial infections/patient (primary endpoint) of 0.017 (98% CI: 0.000, 0.115). Overall, 228 infections were reported, most frequently bronchitis, chronic sinusitis, nasopharyngitis and upper respiratory tract infection. The mean annualized rate of infections was 3.79/patient. A lower risk of infections was associated with an IgG trough level > 8 g/L (p = 0.01). The mean annualized durations of absence from work or school and of hospitalization due to infections were 1.01 and 0.89 days/patient, respectively. The mean serum IgG trough level before the 6th infusion was 7.73 g/L after a mean dose of IqYmune® of 0.57 g/kg. The pharmacokinetic profile of IqYmune® was consistent with that of other intravenous immunoglobulins. Overall, 15.5% of infusions were associated with an adverse event occurring within 72 h post infusion. Headache was the most common adverse event. In conclusion, IqYmune® was shown to be effective and well tolerated in patients with primary immunodeficiency.
Abstract. Introduction. The main factor in ensuring the competitive advantages of the effective functioning of any enterprise, its stable economic development, is the improvement of the efficiency and optimization of the enterprise's costs. Therefore, in order to achieve a high economic and financial result of activity, enterprises of various industries and spheres of operation need effective cost management. Cost management is aimed at the constant search and identification of resource saving reserves, stimulation of resource conservation and cost reduction in order to obtain the effect of commercial calculation based on the results of the enterprise's activities. Purpose. Research of scientific approaches of various scientists to the definition of the concept of �cost management�, determination of cost management functions and systematization of cost management principles at the enterprise. Results. Substantiates the author's position regarding the essence of this concept of �cost management�, which should be considered as an integral system of organizational and functional support and a methodological toolkit of influencing the process of spending, which includes managerial actions , the purpose of which is for the enterprise to obtain a high positive financial result of its activity. It was determined, that cost management at the enterprise involves the performance of general functions inherent in the management of any object and specific functions. It is justified, that consideration of the principles of cost management should be carried out through a thorough coverage of their substantive basis with the disclosure of the opportunities that the enterprise receives in cost management, subject to compliance with one or another principle. The main principles of cost management of the enterprise are summarized, which include the following principles: system-complex approach to cost management; intersubject feedback; resource reservation; continuity of cost management for the production and sale of a specific product; economic validity and reliability of information about costs; the adequacy of the results of management actions regarding costs; independence. Conclusions. The author's position on the essence of cost management is outlined in the article, the general and specific functions of cost management are detailed, and the principles of the cost management process at the enterprise are detailed. It is ensuring maximum compliance of the specified principles at the enterprise that enables the effectiveness of cost management, which is part of the general management system of the enterprise and reflects the efficiency of economic activity.
Стаття присвячена розкриттю суттєвих характеристик сучасних методик оцінки результативності бізнес-процесів на підприємствах роздрібної торгівлі та виявленню серед них найкращих для практичного впровадження в Україні. Для досягнення мети у роботі на підставі системного підходу розглянуто понятійні категорії бізнес-процесів, критерії оцінювання їх ефективності, проблемні аспекти класифікації. Компаративний огляд методик оцінки бізнес-процесів дозволив виокремити короткострокові та довгострокові методики – в залежності від ступеня змін і тривалості використання; проаналізувати бізнес-процеси за якісними та кількісними показниками у їх системній єдності. Це дало змогу виявити переваги і недоліки найбільш розповсюджених методик оцінки результативності бізнес-процесів за якісними та кількісними на підприємствах роздрібної торгівлі. Огляд інших методик оцінки результативності бізнес-процесів показав, на яких принципах, критеріях та коефіцієнтах, розрахованих за особливим алгоритмом, базуються ці методичні підходи. Узагальнюючи результати аналізу сучасних методик оцінки ефективності, варто зазначити, що фахівці підприємств роздрібної торгівлі, враховуючи позитивні та негативні аспекти методик, мають впроваджувати найкращу методику оцінки ефективності бізнес-процесів, виходячи з особливостей фінансово-господарської діяльності підприємства. Перспективою подальших досліджень є діяльність у напряму удосконалення методичного забезпечення оцінки результативності бізнес-процесів на підприємствах різних галузей економіки.
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The purpose of the article is to study the specifics of the formation of the elemental system of economic analysis of business entities through the prism of its tasks, functions and principles and to develop its general model. The research was conducted using a comparative analysis of methods, functions and principles of economic analysis. The article describes the main types of modern economic analysis, namely: operational analysis, investment analysis, innovation analysis, diagnostic analysis, strategic analysis, marketing analysis, and functional-cost analysis. It has been proven that, like any system of scientific knowledge, economic analysis must contain an object, subject, functions, methods and certain subsystems, which ultimately allow identifying reserves for improving the efficiency of business operations by economic entities. The article proposes a system of economic analysis of business entities, which includes the following elements: subject, object, functions, methodical support, management parameters and strategic and systemic results. It is proven that the methods of economic analysis should be considered from the standpoint of the phases of the production and reproduction process of the enterprise, namely: determination of need, generation of ideas, evaluation of ideas (potential solutions) and results. Because of further research, it is recommended that in order to analyze the economic activity of enterprises and make effective decisions, such promising methods of economic analysis as: situational analysis, strategic analysis, ABC analysis, GAP analysis and institutional analysis need to be developed.
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