Concept formulation for «automated expert workplace»

One of the principle ways of improving the process of the expert evaluation of medicines is the optimization of expert evaluation timing and creation the system, preventing the occurrence of errors. For this purpose the experts of the Federal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation are working on establishment of the concept of creating the information system that would meet all the requirements. The main objectives of the measures taken are the optimization of expert evaluations processes management, automation of manual operations associated with working activities of an expert, specific recommendations for the implementation of collection and storage of primary data, both obtained from analytical instruments and introduced by experts. The authors have considered general principles of «automated expert workplace» concept, the challenge of information technologies elaboration in the sphere of drug development, evaluation and circulation. The role of information systems at each stage of drug life cycle has been defined. A number of optimum approaches to organizing automated expert workplace have been identified

Внедрение системы прослеживания образцов лекарственных средств

The article elaborates on a general overview of the tracing system and the possibilities of its implementation in the circulation of medicines. Moreover, it presents several variants of pharmaceutical production marking and the characteristics of those. The article touches upon the challenges of drug samples tracing system information support.В статье рассматривается общее представление о системе прослеживания и ее возможности внедрения в процессы обращения лекарственных средств. Также в статье представлены варианты маркировки фармацевтической продукции и их характеристики. Затронуты проблемы информационного обеспечения системы прослеживания образцов лекарственных средств

Implementation of automated information systems into the work of the certification body of the federal state budgetary institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation

The article describes the system of electronic document management related to the certification of medicinal immunobiological products (MIBP) in the Scientific Centre for Expert Evaluation of Medicinal Products», as well as historical aspects of its development. It also provides a brief description of CALS - the resources introduced into the expert institution’s activities, which are necessary for maintaining the life cycle of medicinal products. It specifies the main tasks that could be solved with the help of the IS «Document flow related to certification of MIBPs». The article enumerates the main development stages of the information system and its functional capabilities. It contains a review of certain modules of the IS «Document flow related to certification of MIBPs», implemented to meet modern standards of information security. It also summarizes the findings of the development of the IS «Document flow related to certification of MIBPs». The prospects of using the IS «Document flow related to certification of MIBPs» in the expert and scientific activities of the institution are also provided

Development of the Biotechnology for Obtaining a Dietary Supplement From the Selenium-containing Probiotic Cultures Lactobacillus Acidophilus 412/307 and Bifidobacterium Bifidum 1

The relevance of creating a new dietary supplement based on the selenium-containing cultures of lacto- and bifidobacteria was proven. We have chosen the optimal source of selenium – sodium selenite (Na2SeO3), adding which to the cultivation medium of microorganisms ensures maximum accumulation of organic forms of selenium in the examined microorganisms.We have established the effect of concentrations of sodium selenite on an increase in the biomass of lacto- and bifidobacteria. Concentrations of Na2SeO3 exceeding 8 µg/cm3 cause the inhibition of growth in the lactobacilli biomass when compared with control. The growth of biomass of bifidobacteria is inhibited under the influence of the concentration of Na2SeO3 above 5 µg/cm3. Applying the indicators of optical density, we determined values for a specific growth rate and the duration of generation of biomass of the examined microorganisms. The dynamics of selenium accumulation by the cultures Lactobacillus acidophilus 412/307 and Bifidobacterium bifidum I was studied. A direct dependence was established between the quantitative content of inorganic selenium in the environment of cultivation and the content of organic selenium in bacterial cells. Adding the concentration of sodium selenite equal to 0.5 µg/cm3 provides for obtaining 105 µg of organic selenium per one gram of dry biomass of lactobacilli; this indicator for bifidobacteria is 97.5 µg/g. At a concentration of Na2SeO3 equal to 20 µg/cm3, 4,698 µg of organic selenium is biotransformed in the biomass of lactobacilli and 3,149 µg –in the biomass of bifidobacteria.Based on the data derived, we have developed a technological scheme for obtaining the dietary supplement with the quantitative content of organic selenium at 202.5±1 µg/g. The content of lactobacilli was 1.0×109 CFU/cm3; that of bifidobacteria – 1.2×108 CFU/cm