144 research outputs found

    Aspects of the concept "computer literacy" in the conditions of higher professional pedagogical education

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    For young professionals information and communication technologies open access to knowledge, provide completely new opportunities for the acquisition of professional knowledge and creativity, and they are introduced to the values of world culture. Therefore, the formation of the information culture of the younger generation is a very important task

    Semantics and Pragmatics ofΒ Palindromes in Language and Internet Communication

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    The semantic and pragmatic features of palindromes are considered as an important component of the Russian linguistic picture of the world. The question of establishing the scope and boundaries of the concept of β€œpalindrome” is raised, the specificity of the analysis and interpretation of palindromes in modern linguistic science is characterized, the author’s schemes and classifications of palindromes are proposed based on their structure and semantics. Particular attention is paid to palindromes as an example of linguistic creativity, present both in a literary text and in virtual communication. A review of linguistic research on polyndromia is made. The novelty of the research is seen in the fact that for the first time a comprehensive linguistic analysis of palindromes is carried out as an element of Internet communication, highlighting the most valuable topics and ideas that underlie the modeling of palindromes. It is proved that when palindromes are implemented in the current Internet space, their specificity changes: in contexts, there is a shift in emphasis from aesthetics (form) to pragmatics (content) of palindromes, which fully corresponds to the idea of an anthropocentric paradigm and a semantic-cognitive approach in the study of language

    Recommendations for the Programme of Clinical Trials of Medicinal Products for the Treatment of Influenza

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    The development of new medicinal products to treat influenza is motivated by the limitations of existing treatment options, the emergence of drug resistance, and the health consequences of influenza epidemics associated with the highly contagious nature of the virus. Proper planning and implementation of clinical programmes providing reliable data on the efficacy and safety of medicinal products under development requires adherence to recommendations of the regulatory authorities. At the moment, the Russian Federation, the Eurasian Economic Union, and the European Union lack documented recommendations on conducting clinical trials of anti-influenza medicines. There is a need in national guidelines that will reflect the procedure for conducting clinical trials and establish the required amount of data to be submitted with marketing applications for new anti-influenza products. The aim of this study was to analyse possible regulatory approaches to planning clinical development programmes for anti-influenza medicinal products. The article pays particular attention to phase III studies, as the main studies confirming efficacy and safety. The authors described a clinical development strategy and the requirements for the volume and quality of efficacy and safety data. This article is based on the current Russian recommendations for the design and development of medicinal products and guidelines on their evaluation, as well as the recommendations by the U.S. Food and Drug Administration (FDA). The analysis results demonstrate the necessity for elaborating Russian recommendations for clinical studies of medicinal products for the treatment of influenza that will take into account the national legislation and clinical development practices. Such recommendations will streamline the implementation of new effective anti-influenza medicinal products

    ИспользованиС ΠΌΠ°ΡˆΠΈΠ½Π½ΠΎΠΎΠ±ΡƒΡ‡Π°Π΅ΠΌΡ‹Ρ… ΠΏΠΎΡ‚Π΅Π½Ρ†ΠΈΠ°Π»ΠΎΠ² ΠΌΠ΅ΠΆΠ°Ρ‚ΠΎΠΌΠ½ΠΎΠ³ΠΎ взаимодСйствия для изучСния свойств кристалличСских структур

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    In the process of modeling multilayer semiconductor nanostructures, it is important to quickly obtain accurate values the characteristics of the structure under consideration. One of these characteristics is the value of the interaction energy of atoms within the structure. The energy value is also important for obtaining other quantities, such as bulk modulus of the structure, shear modulus etc. The paper considers a machine learning based method for obtaining the interaction energy of two atoms. A model built on the basis of the Gaussian Approximation Potential (GAP) is trained on a previously prepared sample and allows predicting the energy values of atom pairs for test data. The values of the coordinates of the interacting atoms, the distance between the atoms, the value of the lattice constant of the structure, an indication of the type of interacting atoms, and also the value describing the environment of the atoms were used as features. The coordinates of the atoms, the distance between the atoms, the lattice constant of the structure, an indication of the type of interacting atoms, the value describing the environment of the atoms were used as features. The computational experiment was carried out with structures of Si, Ge and C. There were estimated the rate of obtaining the energy of interacting atoms and the accuracy of the obtained value. The characteristics of speed and accuracy were compared with the characteristics that were achieved using the many-particle interatomic potential β€” the Tersoff potential.Π’ процСссС модСлирования многослойных ΠΏΠΎΠ»ΡƒΠΏΡ€ΠΎΠ²ΠΎΠ΄Π½ΠΈΠΊΠΎΠ²Ρ‹Ρ… наноструктур ΡΡƒΡ‰Π΅ΡΡ‚Π²Π΅Π½Π½ΡƒΡŽ Ρ€ΠΎΠ»ΡŒ ΠΈΠ³Ρ€Π°Π΅Ρ‚ быстроС ΠΏΠΎΠ»ΡƒΡ‡Π΅Π½ΠΈΠ΅ Ρ‚ΠΎΡ‡Π½Ρ‹Ρ… Π·Π½Π°Ρ‡Π΅Π½ΠΈΠΉ характСристик рассматриваСмой структуры. Одной ΠΈΠ· Ρ‚Π°ΠΊΠΈΡ… характСристик являСтся Π·Π½Π°Ρ‡Π΅Π½ΠΈΠ΅ энСргии взаимодСйствия Π°Ρ‚ΠΎΠΌΠΎΠ² Π²Π½ΡƒΡ‚Ρ€ΠΈ структуры. Π—Π½Π°Ρ‡Π΅Π½ΠΈΠ΅ энСргии Π²Π°ΠΆΠ½ΠΎ для получСния ΠΈ Π΄Ρ€ΡƒΠ³ΠΈΡ… Π²Π΅Π»ΠΈΡ‡ΠΈΠ½, Ρ‚Π°ΠΊΠΈΡ… ΠΊΠ°ΠΊ ΠΎΠ±ΡŠΠ΅ΠΌΠ½Ρ‹ΠΉ ΠΌΠΎΠ΄ΡƒΠ»ΡŒ упругости структуры, ΠΌΠΎΠ΄ΡƒΠ»ΡŒ сдвига ΠΈ Π΄Ρ€. Π’ Ρ€Π°Π±ΠΎΡ‚Π΅ Ρ€Π°ΡΡΠΌΠ°Ρ‚Ρ€ΠΈΠ²Π°ΡŽΡ‚ΡΡ способ получСния энСргии взаимодСйствия Π΄Π²ΡƒΡ… Π°Ρ‚ΠΎΠΌΠΎΠ², основанный Π½Π° ΠΌΠ΅Ρ‚ΠΎΠ΄Π°Ρ… машинного обучСния. МодСль, построСнная Π½Π° основС ΠΌΠ°ΡˆΠΈΠ½Π½ΠΎΠΎΠ±ΡƒΡ‡Π°Π΅ΠΌΠΎΠ³ΠΎ ΠΏΠΎΡ‚Π΅Π½Ρ†ΠΈΠ°Π»Π° GAP (Gaussian Approximation Potential), обучаСтся Π½Π° Π·Π°Ρ€Π°Π½Π΅Π΅ ΠΏΠΎΠ΄Π³ΠΎΡ‚ΠΎΠ²Π»Π΅Π½Π½ΠΎΠΉ Π²Ρ‹Π±ΠΎΡ€ΠΊΠ΅ ΠΈ позволяСт ΠΏΡ€Π΅Π΄ΡΠΊΠ°Π·Π°Ρ‚ΡŒ значСния энСргии ΠΏΠ°Ρ€ Π°Ρ‚ΠΎΠΌΠΎΠ² для тСстовых Π΄Π°Π½Π½Ρ‹Ρ…. Π’ качСствС ΠΏΡ€ΠΈΠ·Π½Π°ΠΊΠΎΠ² использовались значСния ΠΊΠΎΠΎΡ€Π΄ΠΈΠ½Π°Ρ‚ Π²Π·Π°ΠΈΠΌΠΎΠ΄Π΅ΠΉΡΡ‚Π²ΡƒΡŽΡ‰ΠΈΡ… Π°Ρ‚ΠΎΠΌΠΎΠ², расстояниС ΠΌΠ΅ΠΆΠ΄Ρƒ Π°Ρ‚ΠΎΠΌΠ°ΠΌΠΈ, Π·Π½Π°Ρ‡Π΅Π½ΠΈΠ΅ постоянной Ρ€Π΅ΡˆΠ΅Ρ‚ΠΊΠΈ структуры, ΡƒΠΊΠ°Π·Π°Π½ΠΈΠ΅ Π½Π° Ρ‚ΠΈΠΏ Π²Π·Π°ΠΈΠΌΠΎΠ΄Π΅ΠΉΡΡ‚Π²ΡƒΡŽΡ‰ΠΈΡ… Π°Ρ‚ΠΎΠΌΠΎΠ², Π° Ρ‚Π°ΠΊΠΆΠ΅ Π·Π½Π°Ρ‡Π΅Π½ΠΈΠ΅, ΠΎΠΏΠΈΡΡ‹Π²Π°ΡŽΡ‰Π΅Π΅ ΠΎΠΊΡ€ΡƒΠΆΠ΅Π½ΠΈΠ΅ Π°Ρ‚ΠΎΠΌΠΎΠ².Β  Π’Ρ‹Ρ‡ΠΈΡΠ»ΠΈΡ‚Π΅Π»ΡŒΠ½Ρ‹ΠΉ экспСримСнт проводился с участиСм ΠΎΠ΄Π½ΠΎΠΊΠΎΠΌΠΏΠΎΠ½Π΅Π½Ρ‚Π½Ρ‹Ρ… соСдинСний, Ρ‚Π°ΠΊΠΈΡ… ΠΊΠ°ΠΊ Si, Ge ΠΈ Π‘. ΠžΡ†Π΅Π½ΠΈΠ²Π°Π»ΠΈΡΡŒ ΡΠΊΠΎΡ€ΠΎΡΡ‚ΡŒ получСния энСргии Π²Π·Π°ΠΈΠΌΠΎΠ΄Π΅ΠΉΡΡ‚Π²ΡƒΡŽΡ‰ΠΈΡ… Π°Ρ‚ΠΎΠΌΠΎΠ², Π° Ρ‚Π°ΠΊΠΆΠ΅ Ρ‚ΠΎΡ‡Π½ΠΎΡΡ‚ΡŒ ΠΏΠΎΠ»ΡƒΡ‡Π΅Π½Π½ΠΎΠ³ΠΎ значСния. Π₯арактСристики скорости ΠΈ точности ΡΡ€Π°Π²Π½ΠΈΠ²Π°Π»ΠΈΡΡŒ со значСниями, ΠΏΠΎΠ»ΡƒΡ‡Π΅Π½Π½Ρ‹ΠΌΠΈ с ΠΏΠΎΠΌΠΎΡ‰ΡŒΡŽ многочастичного ΠΏΠΎΡ‚Π΅Π½Ρ†ΠΈΠ°Π»Π° ΠΌΠ΅ΠΆΠ°Ρ‚ΠΎΠΌΠ½ΠΎΠ³ΠΎ взаимодСйствия β€” ΠΏΠΎΡ‚Π΅Π½Ρ†ΠΈΠ°Π»Π° ВСрсоффа.

    Characteristics of Personal Value Motivational Sphere in Psychologists and Psychiatrists

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    Introduction. This study investigates the characteristics of personal value motivational sphere in psychologists and psychiatrists at the stage of professional self-realization. Previous studies in this field have mainly been focused on studying the formation of psychological readiness for work at the stage of professional training or when entering into professional activity. Further stages of the professionalization of physicians and psychologists are most often considered in the context of professional burnout. The presence of stressful situations and emotional tension are characteristic of professional activities of psychologists and psychiatrists. This study compares the characteristics of value motivational sphere in these professional groups. Methods. The study used the following techniques: (a) Diagnostics of Personal Motivational Structure, (b) Personality Orientation, (c) Cognitive Orientation, (d) MAS, (e) Motivation of Affiliation, (f) Motivation of Labor Activity, (g) Value Orientations, (h) Assessment of Satisfaction of Needs by the Method of Paired Comparisons, and (i) Degree of Tension. The differences between the two groups were assessed using Fisher’s angular transformation. Results. This study revealed certain differences in personal value motivational sphere in psychiatrists and psychologists. In the group of psychiatrists personal motivational orientation is more related to social status and livelihood. General activity and social utility are most important characteristics in the group of psychologists. Besides, psychologists are characterized by a high level of cognitive needs; needs for self-realization and social needs are more important for psychiatrists. The findings of the study correlate well with the characteristics of value orientations. Thus, the instrumental value of β€˜education’ is more important for psychologists; the value of β€˜tolerance’ is more important for psychiatrists. Discussion. The authors suggest that in the process of professional self-realization certain characteristics of value motivational sphere in psychiatrists and psychologists may contribute to the formation of their successful professional activity. On the contrary, there are characteristics of value motivational sphere that may lead to emotional burnout

    Uterine leiomyoma in the pediatric population: literature review

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    Uterine fibroids are the most common benign neoplastic tumor of the uterus, occurring in adolescents with a frequency of less than 1%. According to literature data, 87.5% of young patients, as a rule, have a variety of symptoms, the most frequent of which is abnormal uterine bleeding, anemizing the patient, abdominal pain, abdominal enlargement in volume. Diagnosis in adolescent girls may be difficult, due to the rarity, as well as the presence of some limitations in the echographic examination performed, as a rule, by transabdominal access. Methods of treating leiomyomas in women are well known and are widely described in clinical guidelines ranging from surgical to medicinal, however, they are not standardized for the pediatric population. Currently, no more than 25 clinical observations have been described in the literature, which indicates the importance of accumulating clinical data in order to develop an optimal clinical approach aimed at preserving reproductive function in such patients

    ΠœΠ½ΠΎΠ³ΠΎΠΌΠ°ΡΡˆΡ‚Π°Π±Π½ΠΎΠ΅ ΠΌΠΎΠ΄Π΅Π»ΠΈΡ€ΠΎΠ²Π°Π½ΠΈΠ΅ кластСров Ρ‚ΠΎΡ‡Π΅Ρ‡Π½Ρ‹Ρ… Π΄Π΅Ρ„Π΅ΠΊΡ‚ΠΎΠ² Π² ΠΏΠΎΠ»ΡƒΠΏΡ€ΠΎΠ²ΠΎΠ΄Π½ΠΈΠΊΠΎΠ²Ρ‹Ρ… структурах

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    Clusters of point and extended defects, arising in semiconductors as a result of radiation exposure, allow structures to acquire various properties that can be used in the manufacture of new generation devices for nanoelectronics. Numerical simulation of semiconductor materials used to research such processes is a resource-intensive and multifaceted task. To solve it, the multiscale modeling complex was created and the multiscale composition containing instances of basic composition models was set. An algorithm was developed that allows speeding up calculations for systems of large dimensions and accounting for a large number of interacting atoms. The structure of silicon with a complex of point defects was considered as a model. Molecular dynamics simulation was performed using the multiparameter potential of Tersoff. For the calculations, an effective approach to the implementation of parallel computing was presented, and software for parallelizing the computations was used, placed on the hybrid high-performance computing complex of the FRC Β«Computer Science and ControlΒ» of Russian Academy of Science. To implement the parallelized algorithm, the OpenMP standard was used. This approach has significantly reduced the computational complexity of the calculations.It was shown that the developed high-performance software can significantly accelerate molecular dynamics calculations, such as the calculation of divacancy communication energy, due to the parallelization algorithm.ΠšΠ»Π°ΡΡ‚Π΅Ρ€Ρ‹ Ρ‚ΠΎΡ‡Π΅Ρ‡Π½Ρ‹Ρ… ΠΈ протяТСнных Π΄Π΅Ρ„Π΅ΠΊΡ‚ΠΎΠ², Π²ΠΎΠ·Π½ΠΈΠΊΠ°ΡŽΡ‰ΠΈΠ΅ Π² ΠΏΠΎΠ»ΡƒΠΏΡ€ΠΎΠ²ΠΎΠ΄Π½ΠΈΠΊΠ°Ρ… Π² Ρ€Π΅Π·ΡƒΠ»ΡŒΡ‚Π°Ρ‚Π΅ Ρ€Π°Π΄ΠΈΠ°Ρ†ΠΈΠΎΠ½Π½ΠΎΠ³ΠΎ воздСйствия, ΠΏΠΎΠ·Π²ΠΎΠ»ΡΡŽΡ‚ структурам ΠΏΡ€ΠΈΠΎΠ±Ρ€Π΅Ρ‚Π°Ρ‚ΡŒ Ρ€Π°Π·Π»ΠΈΡ‡Π½Ρ‹Π΅ свойства, ΠΊΠΎΡ‚ΠΎΡ€Ρ‹Π΅ ΠΌΠΎΠ³ΡƒΡ‚ Π±Ρ‹Ρ‚ΡŒ ΠΈΡΠΏΠΎΠ»ΡŒΠ·ΠΎΠ²Π°Π½Ρ‹ ΠΏΡ€ΠΈ ΠΈΠ·Π³ΠΎΡ‚ΠΎΠ²Π»Π΅Π½ΠΈΠΈ ΠΏΡ€ΠΈΠ±ΠΎΡ€ΠΎΠ² Π½ΠΎΠ²ΠΎΠ³ΠΎ поколСния для наноэлСкроники. ЧислСнноС ΠΌΠΎΠ΄Π΅Π»ΠΈΡ€ΠΎΠ²Π°Π½ΠΈΠ΅ ΠΏΠΎΠ»ΡƒΠΏΡ€ΠΎΠ²ΠΎΠ΄Π½ΠΈΠΊΠΎΠ²Ρ‹Ρ… ΠΌΠ°Ρ‚Π΅Ρ€ΠΈΠ°Π»ΠΎΠ², примСняСмоС для изучСния Ρ‚Π°ΠΊΠΈΡ… процСссов, β€” это рСсурсоСмкая ΠΈ многограная Π·Π°Π΄Π°Ρ‡Π°. Для Π΅Π΅ Ρ€Π΅ΡˆΠ΅Π½ΠΈΡ создан комплСкс ΠΌΠ½ΠΎΠ³ΠΎΠΌΠ°ΡΡˆΡ‚Π°Π±Π½ΠΎΠ³ΠΎ модСлирования ΠΈ Π·Π°Π΄Π°Π½Π° ΠΌΠ½ΠΎΠ³ΠΎΠΌΠ°ΡΡˆΡ‚Π°Π±Π½Π°Ρ композиция, содСрТащая экзСмпляры Π±Π°Π·ΠΎΠ²Ρ‹Ρ… ΠΌΠΎΠ΄Π΅Π»Π΅ΠΉ-ΠΊΠΎΠΌΠΏΠΎΠ·ΠΈΡ†ΠΈΠΉ. Π Π°Π·Ρ€Π°Π±ΠΎΡ‚Π°Π½ Π°Π»Π³ΠΎΡ€ΠΈΡ‚ΠΌ, ΠΏΠΎΠ·Π²ΠΎΠ»ΡΡŽΡ‰ΠΈΠΉ ΡƒΡΠΊΠΎΡ€ΡΡ‚ΡŒ расчСты для систСм Π±ΠΎΠ»ΡŒΡˆΠΈΡ… размСрностСй ΠΈ ΡƒΡ‡Π΅Ρ‚Π° большого количСства Π²Π·Π°ΠΈΠΌΠΎΠ΄Π΅ΠΉΡΡ‚Π²ΡƒΡŽΡ‰ΠΈΡ… Π°Ρ‚ΠΎΠΌΠΎΠ². Π’ качСствС ΠΌΠΎΠ΄Π΅Π»ΠΈ рассмотрСна структура крСмния с комплСксом Ρ‚ΠΎΡ‡Π΅Ρ‡Π½Ρ‹Ρ… Π΄Π΅Ρ„Π΅ΠΊΡ‚ΠΎΠ². ΠœΠΎΠ»Π΅ΠΊΡƒΠ»ΡΡ€Π½ΠΎ-динамичСскоС ΠΌΠΎΠ΄Π΅Π»ΠΈΡ€ΠΎΠ²Π°Π½ΠΈΠ΅ ΠΏΡ€ΠΎΠ²Π΅Π΄Π΅Π½ΠΎ с ΠΏΡ€ΠΈΠΌΠ΅Π½Π΅Π½ΠΈΠ΅ΠΌ многопарамСтричСского ΠΏΠΎΡ‚Π΅Π½Ρ†ΠΈΠ°Π»Π° ВСрсоффа. Для расчСтов прСдставлСн эффСктивный ΠΏΠΎΠ΄Ρ…ΠΎΠ΄ ΠΊ ΠΎΡΡƒΡ‰Π΅ΡΡ‚Π²Π»Π΅Π½ΠΈΡŽ ΠΏΠ°Ρ€Π°Π»Π»Π΅Π»ΡŒΠ½Ρ‹Ρ… вычислСний, ΠΈ ΠΏΡ€ΠΈΠΌΠ΅Π½Π΅Π½Ρ‹ ΠΏΡ€ΠΎΠ³Ρ€Π°ΠΌΠΌΠ½Ρ‹Π΅ срСдства распараллСливания вычислСний, Ρ€Π°Π·ΠΌΠ΅Ρ‰Π΅Π½Π½Ρ‹Π΅ Π½Π° Π³ΠΈΠ±Ρ€ΠΈΠ΄Π½ΠΎΠΌ Π²Ρ‹ΡΠΎΠΊΠΎΠΏΡ€ΠΎΠΈΠ·Π²ΠΎΠ΄ΠΈΡ‚Π΅Π»ΡŒΠ½ΠΎΠΌ Π²Ρ‹Ρ‡ΠΈΡΠ»ΠΈΡ‚Π΅Π»ΡŒΠ½ΠΎΠΌ комплСксС ЀИЦ Β«Π˜Π½Ρ„ΠΎΡ€ΠΌΠ°Ρ‚ΠΈΠΊΠ° ΠΈ ΡƒΠΏΡ€Π°Π²Π»Π΅Π½ΠΈΠ΅Β» РАН. Для Ρ€Π΅Π°Π»ΠΈΠ·Π°Ρ†ΠΈΠΈ распараллСлСнного Π°Π»Π³ΠΎΡ€ΠΈΡ‚ΠΌΠ° использован стандарт OpenMP. Π’Π°ΠΊΠΎΠΉ ΠΏΠΎΠ΄Ρ…ΠΎΠ΄ ΠΏΠΎΠ·Π²ΠΎΠ»ΠΈΠ» Π·Π½Π°Ρ‡ΠΈΡ‚Π΅Π»ΡŒΠ½ΠΎ ΡΠ½ΠΈΠ·ΠΈΡ‚ΡŒ Π²Ρ‹Ρ‡ΠΈΡΠ»ΠΈΡ‚Π΅Π»ΡŒΠ½ΡƒΡŽ ΡΠ»ΠΎΠΆΠ½ΠΎΡΡ‚ΡŒ ΠΏΡ€ΠΎΠ²ΠΎΠ΄ΠΈΠΌΡ‹Ρ… расчСтов.Показано, Ρ‡Ρ‚ΠΎ Ρ€Π°Π·Ρ€Π°Π±ΠΎΡ‚Π°Π½Π½ΠΎΠ΅ Π²Ρ‹ΡΠΎΠΊΠΎΠΏΡ€ΠΎΠΈΠ·Π²ΠΎΠ΄ΠΈΡ‚Π΅Π»ΡŒΠ½ΠΎΠ΅ ΠΏΡ€ΠΎΠ³Ρ€Π°ΠΌΠΌΠ½ΠΎΠ΅ обСспСчСниС ΠΌΠΎΠΆΠ΅Ρ‚ Π·Π½Π°Ρ‡ΠΈΡ‚Π΅Π»ΡŒΠ½ΠΎ ΡƒΡΠΊΠΎΡ€ΠΈΡ‚ΡŒ молСкулярно-динамичСскиС расчСты, Π² частности, Ρ‚Π°ΠΊΠΈΠ΅ ΠΊΠ°ΠΊ расчСт энСргии связи дивакансий Π·Π° счСт Π°Π»Π³ΠΎΡ€ΠΈΡ‚ΠΌΠ° распараллСливания

    Π Π΅ΠΊΠΎΠΌΠ΅Π½Π΄Π°Ρ†ΠΈΠΈ ΠΏΠΎ ΠΏΡ€ΠΎΠ³Ρ€Π°ΠΌΠΌΠ΅ клиничСских исслСдований лСкарствСнных ΠΏΡ€Π΅ΠΏΠ°Ρ€Π°Ρ‚ΠΎΠ² для лСчСния Π³Ρ€ΠΈΠΏΠΏΠ°

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    The development of new medicinal products to treat influenza is motivated by the limitations of existing treatment options, the emergence of drug resistance, and the health consequences of influenza epidemics associated with the highly contagious nature of the virus. Proper planning and implementation of clinical programmes providing reliable data on the efficacy and safety of medicinal products under development requires adherence to recommendations of the regulatory authorities. At the moment, the Russian Federation, the Eurasian Economic Union, and the European Union lack documented recommendations on conducting clinical trials of anti-influenza medicines. There is a need in national guidelines that will reflect the procedure for conducting clinical trials and establish the required amount of data to be submitted with marketing applications for new anti-influenza products. The aim of this study was to analyse possible regulatory approaches to planning clinical development programmes for anti-influenza medicinal products. The article pays particular attention to phase III studies, as the main studies confirming efficacy and safety. The authors described a clinical development strategy and the requirements for the volume and quality of efficacy and safety data. This article is based on the current Russian recommendations for the design and development of medicinal products and guidelines on their evaluation, as well as the recommendations by the U.S. Food and Drug Administration (FDA). The analysis results demonstrate the necessity for elaborating Russian recommendations for clinical studies of medicinal products for the treatment of influenza that will take into account the national legislation and clinical development practices. Such recommendations will streamline the implementation of new effective anti-influenza medicinal products.ΠŸΠΎΡΠ»Π΅Π΄ΡΡ‚Π²ΠΈΡ Π²ΡΠΏΡ‹ΡˆΠ΅ΠΊ эпидСмий Π³Ρ€ΠΈΠΏΠΏΠ°, связанных с высококонтагиозным Ρ…Π°Ρ€Π°ΠΊΡ‚Π΅Ρ€ΠΎΠΌ ΠΈΠ½Ρ„Π΅ΠΊΡ†ΠΈΠΈ, Π° Ρ‚Π°ΠΊΠΆΠ΅ ограничСния ΡΡƒΡ‰Π΅ΡΡ‚Π²ΡƒΡŽΡ‰ΠΈΡ… ΠΌΠ΅Ρ‚ΠΎΠ΄ΠΎΠ² лСчСния ΠΈ Π²ΠΎΠ·Π½ΠΈΠΊΠ½ΠΎΠ²Π΅Π½ΠΈΠ΅ лСкарствСнной рСзистСнтности ΠΎΠ±ΡƒΡΠ»Π°Π²Π»ΠΈΠ²Π°ΡŽΡ‚ Π°ΠΊΡ‚ΡƒΠ°Π»ΡŒΠ½ΠΎΡΡ‚ΡŒ Ρ€Π°Π·Ρ€Π°Π±ΠΎΡ‚ΠΊΠΈ Π½ΠΎΠ²Ρ‹Ρ… лСкарствСнных ΠΏΡ€Π΅ΠΏΠ°Ρ€Π°Ρ‚ΠΎΠ² для лСчСния этого заболСвания. НадлСТащСС ΠΏΠ»Π°Π½ΠΈΡ€ΠΎΠ²Π°Π½ΠΈΠ΅ ΠΏΡ€ΠΎΠ³Ρ€Π°ΠΌΠΌΡ‹ ΠΈ ΠΏΡ€ΠΎΠ²Π΅Π΄Π΅Π½ΠΈΠ΅ клиничСских исслСдований, Π³Π°Ρ€Π°Π½Ρ‚ΠΈΡ€ΡƒΡŽΡ‰ΠΈΡ… ΠΏΠΎΠ»ΡƒΡ‡Π΅Π½ΠΈΠ΅ ΠΊΠΎΡ€Ρ€Π΅ΠΊΡ‚Π½Ρ‹Ρ… Π΄Π°Π½Π½Ρ‹Ρ… ΠΎΠ± эффСктивности ΠΈ бСзопасности Ρ€Π°Π·Ρ€Π°Π±Π°Ρ‚Ρ‹Π²Π°Π΅ΠΌΡ‹Ρ… ΠΏΡ€Π΅ΠΏΠ°Ρ€Π°Ρ‚ΠΎΠ², обСспСчиваСтся соблюдСниСм Ρ€Π΅ΠΊΠΎΠΌΠ΅Π½Π΄Π°Ρ†ΠΈΠΉ рСгуляторных ΠΎΡ€Π³Π°Π½ΠΎΠ². На Π΄Π°Π½Π½Ρ‹ΠΉ ΠΌΠΎΠΌΠ΅Π½Ρ‚ Π² Российской Π€Π΅Π΄Π΅Ρ€Π°Ρ†ΠΈΠΈ ΠΈ Евразийском экономичСском союзС ΠΎΡ‚ΡΡƒΡ‚ΡΡ‚Π²ΡƒΡŽΡ‚ Π΄ΠΎΠΊΡƒΠΌΠ΅Π½Ρ‚Ρ‹, содСрТащиС Ρ€Π΅ΠΊΠΎΠΌΠ΅Π½Π΄Π°Ρ†ΠΈΠΈ ΠΏΠΎ ΠΏΡ€ΠΎΠ²Π΅Π΄Π΅Π½ΠΈΡŽ клиничСских исслСдований ΠΏΡ€ΠΎΡ‚ΠΈΠ²ΠΎΠ³Ρ€ΠΈΠΏΠΏΠΎΠ·Π½Ρ‹Ρ… ΠΏΡ€Π΅ΠΏΠ°Ρ€Π°Ρ‚ΠΎΠ². БущСствуСт ΠΏΠΎΡ‚Ρ€Π΅Π±Π½ΠΎΡΡ‚ΡŒ Π² Ρ€Π°Π·Ρ€Π°Π±ΠΎΡ‚ΠΊΠ΅ отСчСствСнного руководства, ΠΎΡ‚Ρ€Π°ΠΆΠ°ΡŽΡ‰Π΅Π³ΠΎ порядок провСдСния клиничСских исслСдований, Π° Ρ‚Π°ΠΊΠΆΠ΅ Ρ€Π΅Π³Π»Π°ΠΌΠ΅Π½Ρ‚ΠΈΡ€ΡƒΡŽΡ‰Π΅Π³ΠΎ Π½Π΅ΠΎΠ±Ρ…ΠΎΠ΄ΠΈΠΌΡ‹ΠΉ объСм Π΄Π°Π½Π½Ρ‹Ρ…, ΠΊΠΎΡ‚ΠΎΡ€Ρ‹Π΅ Π΄ΠΎΠ»ΠΆΠ½Ρ‹ Π±Ρ‹Ρ‚ΡŒ прСдставлСны ΠΏΡ€ΠΈ рСгистрации Π½ΠΎΠ²Ρ‹Ρ… ΠΏΡ€ΠΎΡ‚ΠΈΠ²ΠΎΠ³Ρ€ΠΈΠΏΠΏΠΎΠ·Π½Ρ‹Ρ… ΠΏΡ€Π΅ΠΏΠ°Ρ€Π°Ρ‚ΠΎΠ². ЦСль Ρ€Π°Π±ΠΎΡ‚Ρ‹ β€” ΠΈΠ·ΡƒΡ‡Π΅Π½ΠΈΠ΅ основных Π²ΠΎΠ·ΠΌΠΎΠΆΠ½Ρ‹Ρ… рСгуляторных ΠΏΠΎΠ΄Ρ…ΠΎΠ΄ΠΎΠ² ΠΊ ΠΏΠ»Π°Π½ΠΈΡ€ΠΎΠ²Π°Π½ΠΈΡŽ ΠΏΡ€ΠΎΠ³Ρ€Π°ΠΌΠΌ клиничСских исслСдований лСкарствСнных ΠΏΡ€Π΅ΠΏΠ°Ρ€Π°Ρ‚ΠΎΠ² для лСчСния Π³Ρ€ΠΈΠΏΠΏΠ°. ОсобоС Π²Π½ΠΈΠΌΠ°Π½ΠΈΠ΅ ΡƒΠ΄Π΅Π»Π΅Π½ΠΎ клиничСским исслСдованиям III Ρ„Π°Π·Ρ‹ ΠΊΠ°ΠΊ основным исслСдованиям, ΠΏΠΎΠ΄Ρ‚Π²Π΅Ρ€ΠΆΠ΄Π°ΡŽΡ‰ΠΈΠΌ ΡΡ„Ρ„Π΅ΠΊΡ‚ΠΈΠ²Π½ΠΎΡΡ‚ΡŒ ΠΈ Π±Π΅Π·ΠΎΠΏΠ°ΡΠ½ΠΎΡΡ‚ΡŒ ΠΏΡ€Π΅ΠΏΠ°Ρ€Π°Ρ‚Π°. Описана стратСгия клиничСских исслСдований ΠΏΡ€Π΅ΠΏΠ°Ρ€Π°Ρ‚Π°, трСбования ΠΊ ΠΎΠ±ΡŠΠ΅ΠΌΡƒ ΠΈ качСству Π΄Π°Π½Π½Ρ‹Ρ… ΠΏΠΎ эффСктивности ΠΈ бСзопасности. ΠœΠ°Ρ‚Π΅Ρ€ΠΈΠ°Π» ΠΏΠΎΠ΄Π³ΠΎΡ‚ΠΎΠ²Π»Π΅Π½ Π½Π° основС Π΄Π΅ΠΉΡΡ‚Π²ΡƒΡŽΡ‰ΠΈΡ… Ρ€Π΅ΠΊΠΎΠΌΠ΅Π½Π΄Π°Ρ†ΠΈΠΉ ΠΊ ΠΏΠ»Π°Π½ΠΈΡ€ΠΎΠ²Π°Π½ΠΈΡŽ ΠΈ Ρ€Π°Π·Ρ€Π°Π±ΠΎΡ‚ΠΊΠ΅ лСкарствСнных срСдств Π² Российской Π€Π΅Π΄Π΅Ρ€Π°Ρ†ΠΈΠΈ, руководства ΠΏΠΎ экспСртизС лСкарствСнных срСдств ΠΈ Ρ€Π΅ΠΊΠΎΠΌΠ΅Π½Π΄Π°Ρ†ΠΈΠΉ УправлСния ΠΏΠΎ ΠΊΠΎΠ½Ρ‚Ρ€ΠΎΠ»ΡŽ Π·Π° качСством ΠΏΡ€ΠΎΠ΄ΡƒΠΊΡ‚ΠΎΠ² питания ΠΈ лСкарствСнных срСдств БША. Π’ Ρ€Π΅Π·ΡƒΠ»ΡŒΡ‚Π°Ρ‚Π΅ ΠΏΡ€ΠΎΠ²Π΅Π΄Π΅Π½Π½ΠΎΠ³ΠΎ Π°Π½Π°Π»ΠΈΠ·Π° ΠΏΠΎΠΊΠ°Π·Π°Π½Π° Π½Π΅ΠΎΠ±Ρ…ΠΎΠ΄ΠΈΠΌΠΎΡΡ‚ΡŒ Ρ€Π°Π·Ρ€Π°Π±ΠΎΡ‚ΠΊΠΈ отСчСствСнных Ρ€Π΅ΠΊΠΎΠΌΠ΅Π½Π΄Π°Ρ†ΠΈΠΉ ΠΏΠΎ ΠΏΡ€ΠΎΠ²Π΅Π΄Π΅Π½ΠΈΡŽ клиничСских исслСдований ΠΏΡ€Π΅ΠΏΠ°Ρ€Π°Ρ‚ΠΎΠ² для лСчСния Π³Ρ€ΠΈΠΏΠΏΠ° с ΡƒΡ‡Π΅Ρ‚ΠΎΠΌ спСцифики ΡŽΡ€ΠΈΠ΄ΠΈΡ‡Π΅ΡΠΊΠΈΡ… Π½ΠΎΡ€ΠΌ ΠΈ Ρ‚Ρ€Π°Π΄ΠΈΡ†ΠΈΠΉ российской клиничСской ΠΏΡ€Π°ΠΊΡ‚ΠΈΠΊΠΈ. Π Π°Π·Ρ€Π°Π±ΠΎΡ‚ΠΊΠ° Ρ‚Π°ΠΊΠΈΡ… Ρ€Π΅ΠΊΠΎΠΌΠ΅Π½Π΄Π°Ρ†ΠΈΠΉ ΠΏΡ€ΠΈΠ²Π΅Π΄Π΅Ρ‚ ΠΊ ΡƒΡΠΊΠΎΡ€Π΅Π½ΠΈΡŽ Π²Π²ΠΎΠ΄Π° Π² ΠΏΡ€Π°ΠΊΡ‚ΠΈΠΊΡƒ Π½ΠΎΠ²Ρ‹Ρ… эффСктивных ΠΏΡ€Π΅ΠΏΠ°Ρ€Π°Ρ‚ΠΎΠ² ΠΏΡ€ΠΎΡ‚ΠΈΠ² Π³Ρ€ΠΈΠΏΠΏΠ°
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