Monitoring the Financial Status of an Enterprise as the Most Important Component of the Financial Analysis

Статья посвящена мониторингу финансового состояния предприятия как наиболее важному компоненту финансового анализаyesBelgorod State National Research Universit

Recommendations for the Contents of the “Glycan Profile” Part of a Product Specification File

“Glycan Profile” is a necessary part of manufacturers’ product specification files for monoclonal antibody active ingredients or final products and erythropoietin active ingredients. The expert of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation provides recommendations for a step-by-step presentation of the test procedure, which will allow applicants to align product specification files for Russian- and foreign-produced medicinal products, help experts to minimise or eliminate the need to request additional information from applicants, and will contribute to timely batch release of medicinal products

Recommendations for the Contents of the “Peptide Mapping” Part of a Product Specification File

‘Identification. Peptide mapping’ is a necessary part of manufacturers’ product specification files for therapeutic proteins (active ingredients and final products of monoclonal antibodies, filgrastims, erythropoietins). The expert of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation provides recommendations for a step-by-step presentation of the test procedure, which will allow applicants to align product specification files for Russian- and foreign-produced medicinal products, help experts to minimise or eliminate the need to request additional information from applicants, and will contribute to timely batch release of medicinal products

Recommendations for the Contents of a Product Specification File: Related Substances (HPLC)

This article provides recommendations for documenting an analytical procedure for the determination of related substances by high-performance liquid chromatography in a product specification file (PSF). The article contains a description of specific aspects and a template for the typical contents and layout of the PSF section dedicated to related substances. A unified approach to the PSF content and layout will ensure error-free testing, reliable results, and streamlined regulatory assessments

Рекомендации по оформлению раздела нормативной документации на лекарственные средства: пептидное картирование

‘Identification. Peptide mapping’ is a necessary part of manufacturers’ product specification files for therapeutic proteins (active ingredients and final products of monoclonal antibodies, filgrastims, erythropoietins). The expert of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation provides recommendations for a step-by-step presentation of the test procedure, which will allow applicants to align product specification files for Russian- and foreign-produced medicinal products, help experts to minimise or eliminate the need to request additional information from applicants, and will contribute to timely batch release of medicinal products.При составлении нормативной документации на субстанции и лекарственные препараты на лекарственные средства белковой природы (субстанции и лекарственные препараты следующих групп: моноклональные антитела, филграстимы, эритропоэтины) обязательным требованием является включение показателя «Подлинность. Пептидное картирование». Экспертом ФГБУ «НЦЭСМП» Минздрава России представлены рекомендации по пошаговому изложению методики, что позволит заявителям унифицировать проекты нормативной документации на отечественные и зарубежные лекарственные средства, позволит минимизировать или исключить дополнительные запросы экспертов, будет способствовать своевременному выводу препаратов в гражданский оборот

Рекомендации по оформлению раздела нормативной документации на лекарственные средства: гликановый профиль

“Glycan Profile” is a necessary part of manufacturers’ product specification files for monoclonal antibody active ingredients or final products and erythropoietin active ingredients. The expert of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation provides recommendations for a step-by-step presentation of the test procedure, which will allow applicants to align product specification files for Russian- and foreign-produced medicinal products, help experts to minimise or eliminate the need to request additional information from applicants, and will contribute to timely batch release of medicinal products.При составлении нормативной документации на субстанции и лекарственные препараты моноклональных антител и субстанции эритропоэтинов обязательным требованием является включение показателя «Гликановый профиль». Экспертом ФГБУ «НЦЭСМП» Минздрава России представлены рекомендации по пошаговому изложению методики, что позволит заявителям унифицировать проекты нормативной документации на отечественные и зарубежные лекарственные средства, позволит минимизировать или исключить дополнительные запросы экспертов, будет способствовать своевременному выводу препаратов в гражданский оборот

Modeling of the integrated interaction of the innovation process subjects

Within the scope of the presented article, the category "integration" is used as development process, leading to a new type of innovative process subject interaction with the purpose of growth in competitiveness, uncertainty reduction of innovative product commercialization, cost reductionyesBelgorod State Universit

Training in cooperation with the use of information technology

Training of modern graduate takes place in the conditions of requirements of the Federal state educational standards aimed at development of students’ competences. In order to train a competent graduate, higher education institutions are looking for ways that will make this process more effective and dynamic. The purpose of the article is to analyze the experience of higher education institutions in the implementation of training in cooperation with the use of information technology. The wide development of information technologies and their penetration into various spheres of society has determined their implementation in the educational process. The use of information technology is based on the use of personal computers. Now this tool is an integral part of the modern educational process. Placing emphasis on the fact that learning in cooperation is not a fundamentally new technology the authors say that it acquires relevance by incorporating innovative technologies. The article considers the ideas of training in cooperation with the use of information technologies, raises the importance and significance of this issue in modern educational conditions. Training in cooperation expands the students' information field. On the basis of the study of scientific literature, the features of training in cooperation, its essence and value purpose for the formation of competence of students of pedagogical University are highlighted. The study suggests an increase in students ' motivation to study materials after the introduction of information technologies that allow them to be more mobile and creative. The process of mutual learning in the process of cooperation becomes more effective. The higher the motivation of the student to study the discipline is, the higher the level of his knowledge is. The results of the study can be used in the further implementation of information technologies for the development of the learning process in cooperation

Genesis of the Russia’s economy innovative development

The innovative development of economy in Russia is possible only if the way of development will be based on the objective basic components, i.e. the corresponding system of premises and factors determining the innovative process. Namely the latter ensure a transformation of the fundamental processes into the application ones, as well as the dynamic development of the economy under the new trends and patterns influenceyesBelgorod State Universit

Рекомендации по оформлению раздела нормативной документации на лекарственные средства: родственные примеси (для метода ВЭЖХ)

This article provides recommendations for documenting an analytical procedure for the determination of related substances by high-performance liquid chromatography in a product specification file (PSF). The article contains a description of specific aspects and a template for the typical contents and layout of the PSF section dedicated to related substances. A unified approach to the PSF content and layout will ensure error-free testing, reliable results, and streamlined regulatory assessments.Предложены рекомендации изложения в нормативной документации методики оценки качества лекарственных средств по показателю «Родственные примеси» при использовании метода ВЭЖХ. Рассмотрены особенности и предложена типовая схема редакционного оформления раздела «Родственные примеси». Унификация изложения и оформления текста нормативной документации позволит безошибочно выполнять испытание, получать достоверный результат и упростит экспертизу лекарственных средств