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Formulation of the problem. The problem of developing and implementing exploration technology that will ensure the protection of mine workings and prevent catastrophes in the development of coal deposits is especially relevant now, when the issue of environmental protection and safety at coal mines is very acute. Analysis of recent research and publications. The idea of degassing of the Earth as a global process of its self-organization was developed by V.I. Vernadsky in a number of works published in 1911, 1912, 1924. This concept has had and continues to have a powerful growing influence on modern Earth sciences. The idea of the key role of hydrogen in degassing of the Earth is developed in the works of V.M. Larin, F.A. Letnykov, А.А. Marakushev, V.V. Khmelyovska, A.V. Shcherbakov, N.D. Kozlova, Yu.A. Kolyasnikov, V.M. Shestopalov, V.I. Starostenko, A.N. Ponomarenko. The purpose of the article is: analysis of the current state of coal mining in Ukraine and in the world as a whole; substantiation of the possibility of using the technology of safe search for hydrogen in minefield development zones. Presentation of the main research material. The new development of safe exploration technology for coal deposits, proposed by the authors, will allow to track in advance, to identify places of possible manifestations of gas-dynamic phenomena and to make operational decisions to eliminate them. The technology is based on the use of exploratory gas-geochemical methods for mapping the places of gas-hydrogen accumulations and together with a set of geological and geophysical methods allows to allocate areas of possible emergency processes in the development zones of mine fields. On a large massif of field work of areal and profile surveys, the feasibility of using search technology has been proven to justify the use of advance degassing wells to prevent uncontrolled explosive processes and technical disasters. The proposed technology has been tested at numerous mining sites in the process of exploration and environmental research in areas of operating and developed mine fields. Conclusions. For the first time in the world practice, new approaches were proposed and substantiated to change the safety paradigm of coal mining, which will prevent the manifestations of unpredictable GDP and the associated material and human losses. Analysis of the results of a complex of fundamental and applied research at coal mining facilities allows, according to the proposed technology, to identify and map the studied areas of abnormal hydrogen concentrations, their characteristics and use it as reliable markers for operational decisions for safe mining by laying advance degassing wells, which will ultimately make emergency GDP impossible. The expediency of application of the proposed technology for substantiation and allocation of geodynamic active and stable zones and blocks promising for industrial exploration of hydrocarbons, determining the locations of possible manifestations of GDP and complex making operative decisions for safety of mining works is proved. And, unfortunately, the research carried out by scientists and the results obtained have not yet found worthy support from the President of Ukraine, state line ministries, commercial structures and the Academy of Sciences. [ABSTRACT FROM AUTHOR]

Процесс секьюритизации ислама в Центральной Азии рассматривается в рамках трех секторов: военного, политического и социального. Утверждается, что секьюритизация - это не только речевой акт, но и связанный с ним политический процесс, который влияет на принятие законов, касающихся традиций, свободы совести, религиозных объединений, общественных организаций, политических партий и политики безопасности. Представлены способы, при помощи которых ислам в многообразном его понимании был конструирован как угроза. Деконструированы и проанализированы предпосылки такой политики, а также ее последствия для политической системы рассмотренных государств; в частности, для репродукции авторитаризма. В начале статьи кратко излагаются основные положения теории секьюритизации. Во второй части анализируется военный аспект, в котором исламский радикализм представлен как угроза безопасности государства и населения, территориальной целостности или военному потенциалу. Затем рассматривается политический аспект, в рамках которого в исламском радикализме усматривают угрозу суверенитету государства, его институтам, а также стабильности и устойчивости социального порядка. Завершающая часть статьи посвящена дискурсу и практике социального аспекта секьюритизации, согласно которому исламский радикализм угрожает коллективной идентичности, языку и культуре. [ABSTRACT FROM AUTHOR]

Copyright of Security: Theory & Practice / Bezpieczeństwo.Teoria i Praktyka is the property of Andrzej Frycz Modrzewski Krakow University, AFM Publishing Office and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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Copyright of Technical Electrodynamics / Tekhnichna Elektrodynamika is the property of National Academy of Sciences of Ukraine, Institute of Electrodynamics and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Актуальность исследования обусловлена тем, что обеспечение социальной безопасности молодежи является важнейшим инструментов в решении множества проблем этой возрастной группы, что, в настоящее время, может стать для нашей страны ключевым фактором и основой успешного социально-экономического развития. Целью данной работы является исследование оценок социальной и личной безопасности молодежью Волгоградской области. Эмпирической базой являются данные социологического исследования, проведенного научным коллективом Алтайского государственного университета в 2019 году. По результатам исследования, молодежь Волгоградской области беспокоит обеспечение экономической безопасности (уровень материального благосостояния населения), проблемы собственной реализации и перспектив, коррупция и произвол власти. В связи с этим респондентами были высказаны мнения о необходимости принятия мер по обеспечению социальной безопасности населения данного региона – повышение уровня жизни населения области, борьба с безработицей, улучшение работы правоохранительных органов. Научная новизна исследования состоит в анализе социальной безопасности молодежи в контексте социально-экономического развития региона проживания. Практическая ценность исследования заключается в представлении актуальных оценок социальной безопасности молодежи региона, что позволит государству и другим агентам безопасности принимать меры для улучшения ситуации в регионе по данному вопросу.

Проблемная область исследования охватывает рассмотрение, а также анализ обеспечения личной безопасности граждан современного казахстанского общества. Целью настоящей работы является выявление, изучение и теоретическая концептуализация сведений о личной безопасности в качестве показателя качества жизни населения. Для достижения цели исследования были использованы такие общенаучные методы как анализ и синтез, методы сравнения, функциональный и логический анализ, а также методы прикладных исследований. В работе проведен ретроспективный анализ возникновения понятия «личная безопасность», систематизированы существующие подходы к исследованию сущности, что позволило выделить основные ее компоненты. В работе личная безопасность рассматривается в качестве одного из базовых потребностей человека, который влияет на качество жизни населения. В данном контексте проведен анализ существующих методик оценки качества жизни населения, учитывающих факторы личной безопасности. На основании рассмотренных методик и по результатам исследований международных организаций проведен сравнительный анализ показателей, связанных с личной безопасностью, Казахстана и стран ОЭСР по различным индексам. Проведенные сравнения позволили дать некотрую оценку состояния личной безопасности граждан Казахстана. Также используя методику линейной комбинации частных показателей в интегрированный показатель, авторами рассчитан показатель экономической безопасности населения для Алматинской области, который охватывает показатели личной безопасности. Авторами выделены преимущества и недостатки примененной методики, и даны рекомендации по ее использованию на различных уровнях. Выводы исследования могут быть взяты за основу для проведения более углубленных исследований по измерению показателей личной безопасности населения в контексте обеспечения качества жизни.

Статья посвящена истории философского осмысления феномена безопасности. Рассмотрены онтологические аспекты явления, а также концептуальное оформление термина в Античности, Средневековье, Новом и Новейшем времени в Западной Европе и России. Особое внимание уделено тематизации проблем безопасности на каждом их указанных этапов.

Hardware-software systems are widely used now and must be safe and reliable. Manual analysis of risks for structural complex systems is very expensive, so formal automated methods are required. The most important aspect here is the possibility to describe safety requirements in terms used in safety theory, such as Markov chains or logic-probabilistic functions, since for the decades of development of the theory, a large number of very useful results have been accumulated. Different approaches to assessing safety of systems do not compete, but complement each other, so having some universality in describing safety requirements is a very valuable quality. In this article, we demonstrate the advisability of using the AADL modeling language and its extension Error Model Annex to describe safety requirements of a system under design. First, we describe a mathematical model of safety requirements expressible in AADL Error Model Annex. Next, we present algorithms to perform the following automated risk analysis on the base of AADL models: Fault Tree Analysis (including calculation of minimal cut sets and ranking of primary events with respect to different relevant importance measures), Failure Mode and Effects Analysis, and Markovian Analysis. At last, we consider an example of a real avionic system. We present an architecture of an AADL model of the system under design and describe how to develop Error Model Annex specifications for the model. With the help of risk analysis, we show how one can identify, localize and fix a bug in the architecture of the system on the design stage of the system development. All presented algorithms are implemented in MASIW framework for design of modern avionics systems.

The analysis of models and methods of reliability evaluation of hardware and software is carried out. The basic concepts of reliability and safety methods of such systems and situations leading to errors, defects and failures are defined. The definition of reliability and safety of technical systems and software systems is given. The classification of reliability models: predictive, measuring and evaluation types. Evaluation models that are used more in practice are described. The standard of Software life cycle (ISO 15288:2002) is defined, focused on the development and control of system components for errors, starting with the system requirements. The results of application of reliability models (Moussa, Goel-Okomoto, etc.) to small, medium and large projects are presented and their comparative assessment is given. The technological module (TM) of reliability evaluation of complex software systems VPK (1989) is described. The quality model of the standard ISO 9126 (1-4): 2002-2004 with indicators of functionality, reliability, efficiency, etc., which are used in determining the maturity and certificate of the product is shown.

Authentication is associated with a scenario, in which some party (the applicant) presented the identity of the principal and states that this is the principal. Authentication allows some other party (verifier) to make sure that this statement is legitimate. Authentication is widely used in access control systems to networks and resources of computing systems. In this context, of considerable interest is the Extensible Authentication Protocol (EAP), specified by the IETF in RFC 3748, which provides an effective mechanism for embedding various authentication methods into it, as well as the proper methods of EAP authentication, some of which were standardized in specifications IETF. This article is a review of Extensible Authentication Protocol (EAP) and its methods, specified by IETF. EAP provide an effective flexible authentication mechanism that can be easily expanded with new authentication methods. The variety of mechanisms used to implement the authentication service are shown. The work was performed under support of the Russian Foundation for Basic Research, research grant № 16-07-00603 "The verification of security functionality of the EAP authentication protocol and evaluation of the robustness of its implementations against attacks".

The article deals with the study of the relation of students of institutes of higher education to the use of amulets, talismans, and charm as artifacts of safety. Artifacts of safety are material symbols the use of which involves improving the efficiency of self-safety. The considered artifacts entered into the system of subjective views of students; they believed in their effectiveness as means of defense and well-being of the person. The understanding of the purpose of amulets, talismans, and charms, established in the cultural space, formed the basis of this belief. This belief is rather a kind of social tradition; it presupposes own experience or magical orientation of the personality of the respondents only partially. Defense was the most attributive sphere of activity of the considered artifacts; they also could bring success and happiness. The study showed significant syncretism of students’ representations of the nature and functionality of the artifacts of safety. Their successful differentiation was based on the discrimination of origin and the nature of force. Despite the presence of the belief in the artifacts of safety, the overwhelming majority of the students were ready to use them in the present and especially in the future. The students explained the demand for the artifacts of safety in the future by the desire to ensure the protection of children. The authors distinguished and interpreted two groups of contradictions: (a) between the declared belief in the efficacy of the artifacts of safety and the subjects’ willingness to use them; (b) between the declared willingness to use the artifacts of safety and their actual use at the present time.

Objective: on the basis of sociological research, to analyze, study and disclose the essential characteristics of public opinion of Nizhny Novgorod citizens on the state of law and order and security in the metropolis; to formulate recommendations to employees of the internal affairs bodies engaged in providing public order during cultural and sports events, in particular, World Cup 2018.Methods: general scientific (analysis, system-structural approach to the analysis of the study object, comparative-legal method), as well as logical and specific methods (survey method - a survey of Nizhny Novgorod residents).Results: the characteristics of public opinion of Nizhny Novgorod citizens on the level of law and order and security in the metropolis are identified and classified; the factors that provide the feeling of the greatest security and safety, as well as the attitude to World Cup 2018 in different categories of the population are determined; the typology of population groups is carried out depending on the attitude to conducting other large-scale events in the city.Scientific novelty: the article, based on the analysis of public opinion of Nizhny Novgorod residents, for the first time identifies and systematizes the main characteristics, including the problem ones, of the state of law and order and security in the Nizhniy Novgorod metropolis, proposals and practical recommendations were formulated on increasing the efficiency of activity of the regional internal affairs bodies during mass cultural, international, sports events: a) account of the particular location of the settlement, which will host a mass event; b) the internal affairs bodies’ administration should constantly be in a dialogue with the district administrations of the municipality on the issues of crime prevention; c) the citizens should be legally informed about the peculiarities of behavior during mass events; d) increased requirements for the appearance, culture of communication and competence of police officers during mass events; e) strengthening control over visitors from the region or the nearest regions and their stay in the central part of the city.Practical significance: the study results can be used to adjust the work of the territorial bodies of the Russian Ministry of Internal Affairs to optimize and improve activities to ensure law and order and security as a whole, and in the case of the organization of cultural, sports, including international, events. The results of the study can be used in the organization of work to improve the efficiency of the regional internal affairs bodies, to ensure the planning of operational activities and the development of appropriate management decisions in law enforcement.

Бұл мақала ұлттық экономикалардың қаржылық тұрақтылығы мен экономикалық қауіпсіздігін қамтамасыз етуге арналған. Тұрақты қаржы жүйесін құру, экономикадағы дағдарысқа әсер етуі мүмкін ортақ бағыттарды анықтау қарастарылған, тұрақтылық пен экономикалық қауіпсіздікті қамтамасыз ететін макроэкономикалық көрсеткіштерді кеңейту туралы талқыланған.Интеграция және жаһандану жағдайында халықаралық экономикалық одақтар мен ұйымдарға қосылу, олардың мүшесі болу экономикалық процестерді тиімді басқару және реттеу, қауіпсіздікті қамтамасыз ету мүмкіндігін арттыра отырып, сонымен қатар ықтимал қатерлерді тудыруы мүмкін.Экономиканың қазіргі заманғы моделі қаржы нарығы мен саяси үрдістерге байланысты, ал мақсаты - модель элементтерінің жұмыс істеу ережелері мен механизмдерін өзгерту. Өсу әлеуетін арттыру үшін құрылымдық реформаларды жүргізу қажет. Дамыған және дамушы елдердің экономикасын қалпына келтіруге қабілетті тұтас механизм болуы керек.

В статье использованы данные, полученные в рамках исследования особенностей проявления доверия и оценок социальной безопасности населения Алтайского края (2019, n = 621) в возрасте от 15 до 75 лет, на основе выделения в общей выборке населения региона подвыборки коренного и диаспорального сообщества, имеющего опыт транзитных перемещений. Получены как оценки личной безопасности перемещающегося населения, так и оценки безопасности регионального социума, принимающего иностранных мигрантов. Большинство респондентов, сами являясь мигрантами, не так давно принятыми в региональном сообществе, отрицательно относятся к мигрантам. Видимо, являясь гражданами России, адаптировавшись в принимающем сообществе, транзитные мигранты становятся на иные, близкие к аборигенному «стационарному» населению позиции. При этом усиливает негативное отношение к мигрантам осознание не исходящей от них угрозы, а, наоборот, ее отсутствие. В представлениях населения ощущение безопасности связано в первую очередь с присутствием мигрантов в российском приграничье, далее имеет значение распространенность негативных социальных стереотипов о миграции и мигрантах, усиливает опасность и низкий социально-экономический статус региона проживания.

Aim of investigation. Nowadays the question, whether pegylated interferon should be completely abandoned in the treatment of chronic hepatitis C (CHC) is still open. Beneficial interferon properties include: absence of mutagenic capacity for hepatitis C virus and drug interaction, stimulation of host immune response. These qualities formed the basis for development of the Russian pegilated interferon-alpha 2b (Pegaltevir®, LLC «FARMAPARK», Russia) and carrying out doublestaged randomized open clinical trial: study of safety, tolerability and pharmacokinetics of Pegaltevir® at single injection of increasing doses in various groups of healthy volunteers - the I stage; studying of efficacy and safety of Pegaltevir® in comparison to PegIntron® (Schering-Plough, USA) at CHC as a part of double antiviral therapy with ribavirin (Rebetol®, Schering-Plough, USA) - the II stage. This article presents results of the II phase of investigation. Material and methods. Original study included 140 adult antiviral treatment-naive patients with CHC and compensated liver function. Patients (aged 18 to 70 years) were distributed into four groups. Group 1 (main group, Pegaltevir®/Rebetol® treatment) - 55 patients, HCV genotype 1; group 2 (comparison group, PegIntron®/Rebetol® treatment) - 20 patients, HCV genotype 1; group 3 (main group, Pegaltevir®/Rebetol® treatment) - 47 patients, non-genotype 1 (2 and 3); group 4 (comparison group, PegIntron®/ Rebetol ® treatment) with non-genotype 1 (2 and 3). Assessment of Pegaltevir® efficacy was carried out in 4 weeks (rapid virologic response, RVR) and 12 weeks of treatment (early virologic response, EVR) in groups 1 and 3 in comparison to corresponding scores in groups 2 and 4 (primary criteria of efficacy were estimated in all 140 patients enrolled in original study. The response rate at the moment of secession of antiviral therapy, the sustained virologic response (SVR), histologic response (comparison of paired liver biopsies) served as secondary efficacy criteria and were estimated in 129 patients who completed treatment. The safety analysis was carried out for each patients included in the protocol who received at least one Pegaltevir® dose in comparison to patients who received at least one dose of PegIntron®, - respectively 102 and 38 patients. Results. RVR was comparable in the Pegaltevir® and PegIntron® groups: 65,6 and 82,4% respectively (p>0,05). RVR frequency genotype one patients was 45,3% in Pegaltevir® treatment group and 66,7% in PegIntron® treatment group (p>0,1). At patients with non-genotype 1 (2 and 3): 92,5 and 100% respectively (p>0,05). RVO did not significantly differ in the studied groups: 91,6 and 97,1% for all genotypes respectively (р>0,1). RVO rate for genotype 1 patients in Pegaltevir® group was 86,8%, in PegIntron® treatment group - 94,4% (р>0,1), in non-genotype 1 patients (2 and 3) it reached 97,6 and 100% in the specified patient groups (р>0,1). Response rate at the moment of treatment secession for Pegaltevir® and PegIntron® was 87,4 and 97,1% respectively for all genotypes (р>0,05). In patients with HCV genotype 1 this score Pegaltevir® treatment group reached 79,3%, in PegIntron® group - 94,4% (р> 0,05), in non-genotype 1 patients (2 and 3) - 97,6 and 100% respectively (р>0,1). SVR rate at Pegaltevir® treatment was 82,1% (for all genotypes), PegIntron® - 82,4% (for all genotypes, p>0,1). In HCV genotype 1 patients in Pegaltevir® treatment group SVR made 73,6%, in PegIntron® treatment group - 83,3%, p>0,1, for non-genotype 1 (2 and 3) - 92,9 and 81,3%, p>0,1. No significant differences between basic and control groups at analysis of paired liver biopsies for fibrosis stage reduction rate, absence of negative changes for fibrosis severity and proportion of patients with fibrosis progression were found. Pegaltevir® and PegIntron® treatment groups were comparable safety profile, adverse events were expected, mainly of mild and moderate severity. Conclusion. The hypothesis of identical efficacy of the Russian drug Pegaltevir® tested in the protocol in comparison to PegIntron® was correct and proved. Safety of Pegaltevir® was comparable to safety of PegIntron® as well.

Aim of the study. To estimate efficacy and safety of 3D mode of interferon­free therapy in patients with subcompensated liver cirrhosis (LC) of HCV etiology (genotype 1b). Material and methods. Original study included the data of 66 patients (26 men and 40 women) with subcompensated LC of HCV etiology (genotype 1b) who underwent interferon­free therapy by ombitasvir/paritaprevir/ritonavir, dasabuvir and ribavirin for 12 weeks (the latter was cancelled at receiving the new data on treatment efficacy after 4 weeks of therapy) in September, 2015, before the drug instruction was updated. Mean age of patients was 56.4±10.0 years. At onset of etiological therapy 21 patients (31.8%) had Child­Pugh score of 9, eleven patients (16.7%) had Child­Pugh 8, 34 patients (51.5%) had Child­Pugh 7. The causes of inefficacy of previous modes of combined antiviral therapy (CAT) included absence of virologic response in 43.9% of the cases, recurrence of HCV replication - in 30.3%, virological breakthrough - in 16.7%, development of serious adverse effects - in 9.1%. Taking into account the change of the group quantity during the course of therapy because of treatment cancellation for safety reasons and the subsequent assessment of its efficacy in patients with early treatment cancellation, the modified «intent­to­treat» (ITT) analysis was the basic method of results evaluation. Along with that «per protocol» (PP) analysis was carried out as well. Results. During the treatment course aviremia in 14 days was achieved in 53.8% of patients (in 35 patients of 65), prompt virologic response - at 79.7% (in 51 of 64 patients). All patients underwent complete 12 week course of CAT (n=60) and those for whom treatment was canceled for safety reasons (n=3) - in terms from 14 to 30 days - sustained virologic response (SVR) in 12 weeks and SVR in 24 weeks was registered. The assessment of liver function compensation degree in 6 months after CAT termination demonstrated 3 to 4 points reduction of the Child-Pugh Score in 21 patients (33.9 %), 1 to 2 points in 35 patients (56.5 %). According to the MELD score the clinical improvement was achieved in 66.1% of patients. The early treatment termination was caused by progression of hepatic encephalopathy symptoms and/or jaundice development (4 cases). Most cases of the progression­related treatment termination due to liver failure were reversible after CAT interruption. Three lethal outcomes after the early treatment termination and 1 patients death in follow­up period were registered. Conclusion. Antiviral therapy in 3D mode for subcompensated LC is highly effective not only in those patients who received complete treatment course, but also in those with early treatment secession. Profiling of 3D therapy safety demonstrated that development of serious adverse effects during the treatment is comparable to outcomes at natural course of subcompensated LC in the absence of etiological therapy.

Aim. To analyze the efficacy, safety and pharmacoeconomic indicators of ocrelizumab in adult patients with primary progressive multiple sclerosis (PPMS). Methods. An information search was conducted in the databases Embase, PubMed, Cochrane and eLibrary.ru. The levels of evidence were determined in the studies. Results. Therapy with ocrelizumab compared with placebo characterized by a decrease in the rate of progression of the disease. Treatment with ocrelizumab was associated with a significant slowdown in progression compared to other drugs: rituximab, fingolimod, myelin basic protein peptide 82–98, intravenous immunoglobulin; plasmapheresis / plasma metabolism, corticosteroids, general irradiation of lymphoid tissue, and other most common adverse events: infusion reactions, nasopharyngitis, upper tract respiratory and urinary tract infections, headaches. Life years and quality-adjusted life years for patients receiving ocrelizumab were 16.11 and 3.33, compared with 15.61 and 2.75 for patients receiving better supportive care, respectively. The annual average potential impact on the budget for 1 patient with PPMS in the treatment of ocrelizumab for 5 years ranged from $ 18,300 to 44 200. Conclusions. Ocrelizumab is the only drug that has proven its clinical efficacy in the previously non-curable type of multiple sclerosis, PPC, with risk profile acceptable with respect to clinical benefits.

В статье рассматриваются основные теоретические подходы к определению понятия энергетической безопасности, анализируются работы отечественных и зарубежных авторов, посвященных исследованию проблем обеспечения энергетической безопасности в Республике Казахстан и за рубежом. Предлагается авторское определение энергетической безопасности, а также исследуется взаимосвязь национальной и энергетической безопасности. Поскольку энергетика стала одним из важнейших факторов обеспечения экономического роста и устойчивого развития людей, наций, обществ и, в конечном счете, человеческой цивилизации в глобальном сценарии XXI века, существует настоятельная необходимость рассматривать энергию как стратегический товар и для анализа национальных, региональных и глобальных стратегий в области энергетики. Энергетическая безопасность и национальная безопасность тесно взаимосвязаны, угрозы первым, скорее всего, перерастут в угрозы к последнему.

В проспективном двойном слепом плацебоконтролируемом клиническом исследовании проводилась оценка эффективности и безопасности толперизона гидрохлорида в лечении рефлекторного мышечного спазма с болевым синдромом.

На протяжении последних двадцати лет медицинское и фармацевтическое сообщества направляют усилия на разработку «защитных механизмов», нацеленных на контроль за новыми медицинскими технологиями (МТ). МТ должна быть безопасной. На предрегистрационном этапе это должно достигаться путём соответствия исследований стандарту GCP, а на пострегистрационном этапе — фармаконадзором. Среди регуляторных органов, осуществляющих фармаконадзор, лидерами являются FDA c системой предварительной квалификации лекарственных средств и ЕМА с многовекторной методикой управления рисками. Настоящая статья посвящена безопасности биологических лекарственных препаратов — биопрепаратов (БП) и состоит из двух основных разделов. В первой части рассмотрены нежелательные реакции, связанные с применение БП. Вторая часть посвящена особенностям системы фармаконадзора в РФ и её возможности отвечать современным реалиям.

В статье рассматриваются нежелательные явления при применении ванкомицина – гликопептидного антибиотика. Спектр побочных эффектов ванкомицина невелик, но большинство неблагоприятных побочных реакций этого препарата являются серьезными. Именно серьезность этих реакций и часто тяжесть проявлений значительно ограничивают применение этого антибиотика.

В связи с истечением срока патентной защиты на биологические фармацевтические препараты, полученные из рекомбинантной ДНК, в мире появляется большое количество биоаналогов (биосинтетический продукт, воспроизведенный в соответствии инновационным биосинтетическим продуктом), в большей или меньшей степени воспроизводящих оригинальный препарат. Качество, безопасность и эффективность биосинтетических продуктов (высокомолекулярные продукты, полученные методом биосинтеза с использованием живых клеток [клеточных линий]: инсулин, гранулоцитостимулирующий фактор, соматропин, эритропоэтин) в значительной степени зависит от процессов производства, очистки и приготовления лекарственных форм. Поэтому, последующие биологические вещества, скорее всего, будут отличаться от исходного продукта.

The article is devoted to the socio-cultural phenomenon of the television Studio and its theatrical and literary background. Partly this research can be attributed to the archeology of media, more precisely, to the archeology of modern television formats aesthetics. One of the most typical television programmes is considered - the combination of Studio conversation and broadcast screen works of different genres. The author supposes that the most important elements of Studio programs are their regularity and controllability, as well as the atmosphere of safe distance from the big world or from many virtual and real worlds. Civilized, planned communication and management of information streams is modeled in the Studio. Therefore, violations of this pattern make such a strong impression. The origins of the necessity for a Studio atmosphere are largely associated with the ancient culture and, to an even greater extent, Renaissance images and moods – the existence in the “charming corner” (locus amoenus), the search for the lost Paradise harmony, awareness of the high value of the spectator and commentator security. … In the Internet era videoblogger’s home becomes the Studio and synthesizes privacy and virtual publicity. The idea of a secure public space of communication no longer prevails, giving way to the idea of total integration of the local "place of action" into the space of infinite real and virtual worlds, which should increase the socio-cultural status of the private territory and its inhabitants. Статья посвящена социокультурному феномену телевизионной студии и его театрально-литературной предыстории. Частично данное исследование может быть отнесено к археологии медиа, точнее, к археологии эстетики современных телевизионных форматов. Рассматривается один из наиболее типичных видов телевизионного вещания — совмещение студийного действа и трансляции экранных произведений различных жанров в рамках единой программы. Автор полагает, что важнейшими элементами студийных программ являются их упорядоченность и контролируемость ведущими, а также атмосфера безопасной дистанцированности от большого мира или от множества виртуальных и реальных миров. В студии моделируется цивилизованное общение и управление информационно-образными потоками. Коммуникация рационализирована, спланирована. Поэтому столь сильное впечатление производят нарушения этого паттерна. Истоки потребности в студийной атмосфере во многом связаны с античными и, в еще большей степени, ренессансными образами и настроениями — пребыванием в «прелестном уголке» (locus amoenus), поисками утраченной райской гармонии, а также развитием индивидуализма и осознанием высокой ценности защищенности человека-зрителя и человека-комментатора. Неслучайно именно в процессе развития ренессансных форм рождается театр, в котором зритель дистанцирован от разыгрываемого представления и не может быть подвергнут никакому воздействию со стороны исполнителей. Неслучайно в трех наиболее показательных для Ренессанса сборниках новелл Чосера, Боккаччо и Маргариты Наваррской созданы своеобразные обрамления для отдельных рассказов – смоделированы ситуации многодневного рассказывания историй и их комментирования в приятном обществе. Телевизионные студийные программы унаследуют функцию безопасного для участников и зрителей, занимательного и эстетически привлекательного действа – наблюдения за большим миром и размышления о нем вслух в светском обществе собеседников. В ХХ в. комфортный, лишенный прозаических бытовых черт интерьер, разновидностью которого является телестудия, занимает место центрального образа идеального публичного пространства. В эпоху интернета комната-студия видеоблогера синтезирует в себе приватность и виртуальную публичность. Идея безопасного публичного пространства общения уже не главенствует, уступая место идее тотальной интегрированности локального «места действия» в пространство бесконечных реальных и виртуальных миров, что должно повысить социокультурный статус приватной территории и ее обитателя.

Среди антигистаминных средств второго поколения выделяется Эбастин, отличный по своему строению. Отли­чие основано на структуре оксипиперидина - прототипа одного из антигистаминных средств первого поколения (дифенилпиралина). Эбастин имеет химическую формулу С32fl3NO2, его молекулярная масса равна 469,64.В действительности главным действующим лекарственным веществом, проявляющим фармакологическую ак­тивность, является карбоксилированный метаболит эбастина - каребастин.Для создания эбастина через атом азота в структуре дифенилпиралина к пиперидиновому кольцу была присоеди­нена длинная алифатическая боковая цепь, что обеспечило большую продолжительность действия, низкую стимули­рующую активность в отношении центральных Н-гистаминовых рецепторов, безопасность для сердечно-сосудис­той системы.

Амлодипин - антагонист кальциевых каналов дигидропиридинового ряда третьего поколения, блокирует медленные кальциевые каналы (каналы L-типа) и препятствует внутриклеточной гиперкальциемии и сокращению гладкомышечной клетки, оказывая сосудорасширяющее действие. Амлодипин обладает длительным действием, что позволяет применять его один раз в сутки. Амлодипин эффективно снижает артериальное давление, не влияя на частоту сокращений сердца у пациентов с артериальной гипертензией. Применяется также в лечении пациентов со стенокардией напряжения, в том числе эффективен при выраженном вазоспастическом компоненте ишемии. Препарат хорошо переносится, вызывая небольшое количество побочных эффектов. Применяется в комбинации с другими антиангинальными и антигипертензивными препаратами.

Questions of replacement of original medicines with generic are discussed. The sintesation of identical medicine is a complex challenge from the technological point of view. It is caused by distinctions in production of substances, influence of the variable pharmaceutical factors giving change of the size of particles, a different amorphous forms, a deviation of structure and quantitative content of impurity. Auxiliary substantion characteristics of a production process of ready dosage forms matter. Data on pharmacokinetic equivalence of each generic to original are necessary. For carrying out pharmacotherapy original medicine which receive as a result of the researches executed under the regulated protocol needs data on comparative therapeutic efficiency and shipping the generic of drugs.

Despite the positive trend in safety provision of service personnel in solid minerals mining and preparation coal companies continue to invest large amounts of money in order to minimize injuries and death cases among their employees, as well as employees of contractors operating at preparation plants, open-cast and underground mines.One of the main factors leading to the dangerous situations’ emergence at any enterprise is a large number of moving parts of mechanisms (conveyor belts, vibration screens, etc.), presence in a restricted space as well as the need to perform labor duties near technological equipment.The simplest and most effective means of protecting maintenance personnel from moving aggregate parts is the presence of fences around dangerous mechanisms. The integrity of fences is controlled by sensors. However, the sensors often fail because of mechanical damages, impulse overvoltages in the power circuit, and hard operating conditions. At the same time, because of production need, maintenance personnel can remove protective barriers. Thus, it is not uncommon for a situation where, on the one hand, there is no mechanism start automatic blocking, on the other hand, the service personnel carry out their labor duties in close proximity of technological equipment moving parts, which in the end can lead to injuries and even death of people.To prevent non-standard start-up of technological equipment, it is proposed to develop an automatic video surveillance system using computer vision techniques. Such systems in real time receive an image from the production site and by processing the information obtained using a computer vision algorithm that uses local binary patterns, detect the maintenance personnel presence at the production site. When identifying a person on the image received from the camcorder, the system generates a signal about the prohibition of starting (stopping) technological equipment.

The article presents the results of studies on the safety and efficacy of long-acting drug for the treatment of multiple sclerosis on the basis of recombinant human interferon beta-1a «PEGylated interferon beta-1a Human» (PEG IFN beta-1a) in monkeys Macaca mulatta in subcutaneous and intramuscular injection. The following doses were used: the maximum tolerated dose - 3.0·106 IU/kg, the intermediate dose - 1.5·106 IU/kg and the minimum dose, which was equivalent to human therapeutic dose of unmodified interferon beta-1a - 0.3·106 IU/kg. Quantify the parameters of pharmacodynamics of the PEG IFN beta-1a after single subcutaneous and intramuscular administration of increasing doses of different groups of monkeys. Evaluated the level and nature of the pathological changes of internal organs (visceral systems) of experimental animals caused by repeated subcutaneous and intramuscular injections of PEG IFN-beta 1a. Based on these studies the drug PEG IFN beta-1a in rhesus monkeys indicated that the drug is efficient (both in single subcutaneous and intramuscular administration) and does not have toxic effects (both in multiple subcutaneous and intramuscular administration) when using a therapeutic dose 0.3·106 IU/kg.

The paper presents the data on safety and efficacy assessment of adjuvants and vaccines with adjuvants at the stages of development and preclinical studies based on international recommendations. The presence of an adjuvant in vaccine content ensures higher expressing and prolonged specific immunity. The origin and nature of adjuvants currently used for various vaccines are different. Adjuvants can be classified by origin, mechanism of action, physical and chemical properties. The finished vaccine may contain one or more adjuvants which can be intended for one antigen or a number of antigens in vaccine content. Antigen-adjuvant combination is a key part in the production of a vaccine with an adjuvant. Due to the diversity of adjuvant nature and their physical and chemical properties and mechanisms of action, as well as to antigens in adjuvant vaccines content, it is rather complicated to plan and to conduct preclinical studies. The present article describes various aspects of preclinical studies of adjuvants and vaccines with adjuvants based on the analysis of current guidelines and requirements.

BCG vaccine for tuberculosis was developed nearly 100 years ago and still remains the only medicine for specific immunological prevention of tuberculosis. Despite the fact it has been actively used for a long time in more than 100 countries, the results of vaccination are very contradictory. The protective effect of BCG vaccination is assessed from 0 to 80%, while the efficacy of BCG vaccination in children, especially in infants, is generally recognized. BCG helps to reduce tenfold the number of tuberculous meningitis and disseminated tuberculosis in children. However BCG neither protects the population from mycobacteria infections nor the adults from pulmonary tuberculosis, although it prevents extrapulmonary tuberculosis. For the last 20 years new tuberculosis vaccines have been intensive developed, their efficacy is believed to exceed the efficacy of BCG vaccine, with the minimized adverse reactions. Nevertheless out of more than 200 tuberculosis vaccine candidates only few were allowed for clinical trials. In the upcoming years the humanity can not count upon a medicine that could replace BCG. Therefore the research efforts should be focused on improving BCG vaccine in order to enhance its protective effect and to reduce adverse effects.

The authors prepared proposals for preventing undesired reactions at application immunobiological medicinal products in the Russian Federation. Given the significant number of osteitis when carrying out vaccination against tuberculosis in a nursing home as BCG and BCG-vaccine, it is proposed to consider with experts of the respective profiles of the question of the possible adjustments in the existing system of prevention of tuberculosis. To ensure timely diagnosis "BCG-ASTIC and destination specific treatment of the disease to carry out consultation with the coordinators of all children under the age of 5 years with a diagnosis of "octet" regardless of the localization of the inflammatory process. When exercising pharmacovigilance for side effects of vaccination against tuberculosis note that unlike bone tuberculosis caused by virulent bacteria, and striking in most cases, the spine, BCG osteitis virtually no this localization, and strike thigh 21, 2% of cases, tibia and fibula - 20%, sternum - 15, 6%, humerus and 11.6%, the bones of the foot is 9, 3%, fin - 8, 5%. It is considered necessary to conduct a complete replacement drugs heterologous sera, especially tetanus toxoid and rabies immunoglobulin from the serum of a horse, on preparations of human serum, as it is implemented in all developed countries. This event will lead to the exclusion of the possibility of allergic reactions of immediate type, including anaphylactic shock, when an emergency prophylaxis of these infections. Registration sterile abscesses after application of drugs DTP vaccine and the absence of such complications after the use of other adsorbed preparations (for example hepatitis In vaccines and vaccine encephalitis) do not exclude the possibility of communication first with the quality of the used sorbent and this allows us to recommend further study and evaluation of physicochemical parameters of the series of sorbent, used in the production of adsorbed vaccine containing the pertussis component.

The purpose of this article is to describe and to examine the utility of new pharmacogenetic approaches in monitoring post-approval drug safety in pregnancy. Data on gene expression in pregnancy and metabolic variation may, in specific instances, help to predict adverse drug reactions in the mother-placenta-fetus complex and to identify individuals at a higher risk.

15-25% of cases of the medicatiom errors caused by the similarity in spelling or pronunciation of their names. The labelling may be a means of protection against such errors. The authors proposed a way of marking that is applied to each unit product information protective barcode labels containing identification and content information. The label is additionally equipped with a diffractive element copy protection, with a surface microrelief, creating the effect of optical diffraction, and the information that should be included in bar code originally entered into the Central computer control institutions of the supporting documents provided by the supplier for each delivered batch of goods, and then by computer conversion of this information on a predefined algorithm that transforms the data from supporting documents by a specific rule that specifies a particular responsible person of the region by entering the password in the set of symbols form a bar code and produce printing batches of labels in the statement of the provider number for a label on each unit of production with application to each barcode labels, and vending facility shall review products by visual inspection of the presence of the diffraction element and the read bar code labels are scanned per unit of output with simultaneous inverse transformation according to a predefined algorithm included in the bar code information and comparing the information from supporting documents submitted by provider for each delivered batch.

Comparative evaluation of information about adverse reactions to medicinal products was carried out on the basis of the research data registered in specialized databases WHO, Russia, Switzerland, USA and the Republic of Kazakhstan. Comparative evaluation of the results of safety monitoring medicines showed that in the Russian Federation the average reporting about adverse reactions below the level recommended by WHO and countries with the most effective system of pharmacovigilance, such as the USA or Switzerland, but higher than in the Republic of Kazakhstan.

The typical pharmacovigilance system master file (PSMF) is presented. MPSF was created on the basis of the Rules of good pharmacovigilance practice for the members of Eurasian economic Union countries. Possible ways of the description of the pharmacovigilance system, all the possible types of MPSP and constituent standard operating procedures are considered. Practical recommendations on preparation and using of MFSF are given.

Systematic evaluation of management principles by signals on medicinal drugs safety is submitted. The sources of signals, the approaches to the detection signal processing and detection, validation, analysis and prioritization, signal assessment are considered. A review of the individual security reports is demonstrated. A statistical analysis of large databases and processes of their regulation was shown. Practical recommendations for the identification of signals in national and international databases are given.

The article presents the results of the Scientific Centre for Expert Evaluation of Medicinal Products», Ministry of Health of Russia of the analysis and generalization of materials on the safety of clinical trials of medicines for medical use (including international multi-center clinical trials), permits for which were issued by the Ministry of Health of Russia. Study materials consist of 38273 submissions of developers of medicines, containing information about 62462 the occurrence of serious adverse events and serious adverse reactions to new drugs, and safety update reports from 1 July 2012 to 31 December 2016. The results of the analysis and generalization of obtained with the use of modern methods of investigation allowed the authors to establish the existence of quantitative and qualitative problems with material of safety clinical studies in 2012-2013. It is shown that already in 2013 the complex was developed and implemented measures helped to solve the identified problems: to increase by 22 times the number of clinical trial materials received from the Russian clinical centers and eliminate problems with the quality of the submissions, which is currently equally acceptable for all developers and organizations conducting clinical research. Recommendations for effective analysis and synthesis of the material safety clinical studies of medicinal products by the regulatory authorities, allowing to quickly make evidence-based decisions in relation to the preparation of recommendations for adoption of administrative decisions in the field of pharmacovigilance and clinical research.

Recently were appeared a fundamentally new insulin-independent approach to the treatment of type 2 diabetes - reduce blood glucose levels by inhibiting proteins co-transporters SGLT2 (sodium glucose transporter) in the proximal tubules of the kidneys, which are responsible for the reabsorption of glucose. Inhibitors SGLT2 co-transporters is effective either as monotherapy or in combination with other antidiabetic drugs. Thus, according to the results of randomized controlled trials, therapy with this class of drugs was well tolerated. The incidence of hypoglycemia was not statistically different from the incidence of hypoglycemia in the placebo group. On the background of therapy was observed a stable decrease in body weight in patients with type 2 diabetes. Therapy with all drugs of a class of SGLT2 inhibitors was accompanied by a decrease in blood pressure and body weight. This class of drugs could potentially play an important role in the early stages of development of diabetic nephropathy, with potential nephrorotective effect, working on the level of reduction intraglomerular pressure of a single nephron. Insulin-independent mechanism of action and low risk of hypoglycaemia makes the SGLT2 inhibitors effective and safe addition to existing methods of control glycemia in patients with type 2 diabetes.

General recommendations for planning and implementing of a risk-based approach to audits of pharmacovigilance systems of Marketing Authorisation Holders are presented. A review of the general requirements for audits and audit reporting is given. The role of the pharmacovigilance system master file in the planning of audits and inspections is discussed. The article contains practical recommendations for the Qualified Person Responsible for Pharmacovigilance in Marketing Authorisation Holders.

RETRACTED ARTICLEBrief description of the opportunities and benefits of applying the methodology of clinical pharmacology and personalized medicine, pharmacokinetics, and pharmacodynamics of medicines, as well as the possibilities of evaluation of metabolic biotransformation and drug interactions to improve the efficacy, safety, therapeutic and pharmacodynamic effects of medicines, is given. These features and techniques should be extensively used for expert evaluation of efficacy and safety of drugs. The introduction of modern methods of diagnostics and treatment in clinical practice will require building a system that could be implemented in the Centres of personalized medicine.

For the purpose of prevention and treatment of various diseases, herbal medicinal products are used along with a wide range of small molecule drugs. Herewith herbal preparations are not only herbs and combined herbal products, but also various galenic and new galenic preparations and individual biologically active compounds derived from plants. The growth of demand for herbal medicinal product, the changing requirements of the regulatory system to their safety and effectiveness during the procedure of registration puts certain tasks to improve this procedure. The article provides an overview of the literature data on contemporary requirements for safety and efficacy assessment of herbal preparations. Analysis of approaches to conducting preclinical and clinical studies of herbal preparations in Russia and the international community led to certain conclusions on the degree of their harmonization and possible unification.

The article analyses the regulatory and legal framework for medicines evaluation in the Russian Federation and abroad, as well as guidelines, scientific literature and practical experience to justify criteria for evaluation of efficacy and safety of homeopathic medicines. When selecting appropriate evaluation criteria the authors took into account specificity of homeopathic medicines composition and dosage form formulation, specific characteristics of pharmaceutical substances and therapeutic action, as well as known limitations on the use of standard test methods. The key criteria for homeopathic medicines evaluation are: compliance of the substance quality and the drug production technology with corresponding pharmacopoeial requirements, substantiation of the drug composition safety, and confirmation of the proposed efficacy and safety by the evidence-based pre-clinical and clinical programme.

In terms of pharmacotherapy, pregnancy is a specific phase of life that is different from all the other phases of the life of medical, ethical and legal framework. The article examines the scientific, ethical and regulatory principles of inclusion of pregnant women in the clinical trials of drugs, the necessity for them is justified from the point of clinical pharmacology. The clinical value assessment studies regarding the expected benefits to the possible risks during the pharmacotherapy in pregnancy necessitates the development of this scientific direction.

The article summarises literature data on clinical management of HIV infection in pregnant women. It discusses the general principles of antiretroviral therapy for HIV-infected pregnant women and prevention of mother-to-child transmission of HIV infection. It also describes pharmacokinetic properties of antiretroviral drugs for pregnant women. The article highlights issues concerning the effects of pregnancy on drug metabolism, patterns of drug interaction with both ABC and SCL drug transporters and associated clinical implications for antiretroviral therapy. The authors demonstrate the need for therapeutic drug monitoring of protease inhibitors in HIV-infected pregnant women.

Рассмотрены аспекты применимости программируемых управляющих систем на атомных станциях. Отмечены преимущества и недостатки этих систем. Основными недостатками названы: невозможность обоснования показателей надежности реализуемых функций управления, подверженность возможным кибератакам. Предложен метод выбора средств автоматизации для реализации управляющих систем на программируемых и не программируемых средствах автоматизации на основе проведения функционального анализа управляющих систем атомной станции.

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