144 research outputs found
Aspects of the concept "computer literacy" in the conditions of higher professional pedagogical education
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
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 βpalindromeβ is raised, the specificity of the analysis and interpretation of palindromes in modern linguistic science is characterized, the authorβs 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
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
ΠΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ΠΈΠ΅ ΠΌΠ°ΡΠΈΠ½Π½ΠΎΠΎΠ±ΡΡΠ°Π΅ΠΌΡΡ ΠΏΠΎΡΠ΅Π½ΡΠΈΠ°Π»ΠΎΠ² ΠΌΠ΅ΠΆΠ°ΡΠΎΠΌΠ½ΠΎΠ³ΠΎ Π²Π·Π°ΠΈΠΌΠΎΠ΄Π΅ΠΉΡΡΠ²ΠΈΡ Π΄Π»Ρ ΠΈΠ·ΡΡΠ΅Π½ΠΈΡ ΡΠ²ΠΎΠΉΡΡΠ² ΠΊΡΠΈΡΡΠ°Π»Π»ΠΈΡΠ΅ΡΠΊΠΈΡ ΡΡΡΡΠΊΡΡΡ
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 ΠΏΡΠΎΡΠ΅ΡΡΠ΅ ΠΌΠΎΠ΄Π΅Π»ΠΈΡΠΎΠ²Π°Π½ΠΈΡ ΠΌΠ½ΠΎΠ³ΠΎΡΠ»ΠΎΠΉΠ½ΡΡ
ΠΏΠΎΠ»ΡΠΏΡΠΎΠ²ΠΎΠ΄Π½ΠΈΠΊΠΎΠ²ΡΡ
Π½Π°Π½ΠΎΡΡΡΡΠΊΡΡΡ ΡΡΡΠ΅ΡΡΠ²Π΅Π½Π½ΡΡ ΡΠΎΠ»Ρ ΠΈΠ³ΡΠ°Π΅Ρ Π±ΡΡΡΡΠΎΠ΅ ΠΏΠΎΠ»ΡΡΠ΅Π½ΠΈΠ΅ ΡΠΎΡΠ½ΡΡ
Π·Π½Π°ΡΠ΅Π½ΠΈΠΉ Ρ
Π°ΡΠ°ΠΊΡΠ΅ΡΠΈΡΡΠΈΠΊ ΡΠ°ΡΡΠΌΠ°ΡΡΠΈΠ²Π°Π΅ΠΌΠΎΠΉ ΡΡΡΡΠΊΡΡΡΡ. ΠΠ΄Π½ΠΎΠΉ ΠΈΠ· ΡΠ°ΠΊΠΈΡ
Ρ
Π°ΡΠ°ΠΊΡΠ΅ΡΠΈΡΡΠΈΠΊ ΡΠ²Π»ΡΠ΅ΡΡΡ Π·Π½Π°ΡΠ΅Π½ΠΈΠ΅ ΡΠ½Π΅ΡΠ³ΠΈΠΈ Π²Π·Π°ΠΈΠΌΠΎΠ΄Π΅ΠΉΡΡΠ²ΠΈΡ Π°ΡΠΎΠΌΠΎΠ² Π²Π½ΡΡΡΠΈ ΡΡΡΡΠΊΡΡΡΡ. ΠΠ½Π°ΡΠ΅Π½ΠΈΠ΅ ΡΠ½Π΅ΡΠ³ΠΈΠΈ Π²Π°ΠΆΠ½ΠΎ Π΄Π»Ρ ΠΏΠΎΠ»ΡΡΠ΅Π½ΠΈΡ ΠΈ Π΄ΡΡΠ³ΠΈΡ
Π²Π΅Π»ΠΈΡΠΈΠ½, ΡΠ°ΠΊΠΈΡ
ΠΊΠ°ΠΊ ΠΎΠ±ΡΠ΅ΠΌΠ½ΡΠΉ ΠΌΠΎΠ΄ΡΠ»Ρ ΡΠΏΡΡΠ³ΠΎΡΡΠΈ ΡΡΡΡΠΊΡΡΡΡ, ΠΌΠΎΠ΄ΡΠ»Ρ ΡΠ΄Π²ΠΈΠ³Π° ΠΈ Π΄Ρ. Π ΡΠ°Π±ΠΎΡΠ΅ ΡΠ°ΡΡΠΌΠ°ΡΡΠΈΠ²Π°ΡΡΡΡ ΡΠΏΠΎΡΠΎΠ± ΠΏΠΎΠ»ΡΡΠ΅Π½ΠΈΡ ΡΠ½Π΅ΡΠ³ΠΈΠΈ Π²Π·Π°ΠΈΠΌΠΎΠ΄Π΅ΠΉΡΡΠ²ΠΈΡ Π΄Π²ΡΡ
Π°ΡΠΎΠΌΠΎΠ², ΠΎΡΠ½ΠΎΠ²Π°Π½Π½ΡΠΉ Π½Π° ΠΌΠ΅ΡΠΎΠ΄Π°Ρ
ΠΌΠ°ΡΠΈΠ½Π½ΠΎΠ³ΠΎ ΠΎΠ±ΡΡΠ΅Π½ΠΈΡ. ΠΠΎΠ΄Π΅Π»Ρ, ΠΏΠΎΡΡΡΠΎΠ΅Π½Π½Π°Ρ Π½Π° ΠΎΡΠ½ΠΎΠ²Π΅ ΠΌΠ°ΡΠΈΠ½Π½ΠΎΠΎΠ±ΡΡΠ°Π΅ΠΌΠΎΠ³ΠΎ ΠΏΠΎΡΠ΅Π½ΡΠΈΠ°Π»Π° GAP (Gaussian Approximation Potential), ΠΎΠ±ΡΡΠ°Π΅ΡΡΡ Π½Π° Π·Π°ΡΠ°Π½Π΅Π΅ ΠΏΠΎΠ΄Π³ΠΎΡΠΎΠ²Π»Π΅Π½Π½ΠΎΠΉ Π²ΡΠ±ΠΎΡΠΊΠ΅ ΠΈ ΠΏΠΎΠ·Π²ΠΎΠ»ΡΠ΅Ρ ΠΏΡΠ΅Π΄ΡΠΊΠ°Π·Π°ΡΡ Π·Π½Π°ΡΠ΅Π½ΠΈΡ ΡΠ½Π΅ΡΠ³ΠΈΠΈ ΠΏΠ°Ρ Π°ΡΠΎΠΌΠΎΠ² Π΄Π»Ρ ΡΠ΅ΡΡΠΎΠ²ΡΡ
Π΄Π°Π½Π½ΡΡ
. Π ΠΊΠ°ΡΠ΅ΡΡΠ²Π΅ ΠΏΡΠΈΠ·Π½Π°ΠΊΠΎΠ² ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π»ΠΈΡΡ Π·Π½Π°ΡΠ΅Π½ΠΈΡ ΠΊΠΎΠΎΡΠ΄ΠΈΠ½Π°Ρ Π²Π·Π°ΠΈΠΌΠΎΠ΄Π΅ΠΉΡΡΠ²ΡΡΡΠΈΡ
Π°ΡΠΎΠΌΠΎΠ², ΡΠ°ΡΡΡΠΎΡΠ½ΠΈΠ΅ ΠΌΠ΅ΠΆΠ΄Ρ Π°ΡΠΎΠΌΠ°ΠΌΠΈ, Π·Π½Π°ΡΠ΅Π½ΠΈΠ΅ ΠΏΠΎΡΡΠΎΡΠ½Π½ΠΎΠΉ ΡΠ΅ΡΠ΅ΡΠΊΠΈ ΡΡΡΡΠΊΡΡΡΡ, ΡΠΊΠ°Π·Π°Π½ΠΈΠ΅ Π½Π° ΡΠΈΠΏ Π²Π·Π°ΠΈΠΌΠΎΠ΄Π΅ΠΉΡΡΠ²ΡΡΡΠΈΡ
Π°ΡΠΎΠΌΠΎΠ², Π° ΡΠ°ΠΊΠΆΠ΅ Π·Π½Π°ΡΠ΅Π½ΠΈΠ΅, ΠΎΠΏΠΈΡΡΠ²Π°ΡΡΠ΅Π΅ ΠΎΠΊΡΡΠΆΠ΅Π½ΠΈΠ΅ Π°ΡΠΎΠΌΠΎΠ².Β ΠΡΡΠΈΡΠ»ΠΈΡΠ΅Π»ΡΠ½ΡΠΉ ΡΠΊΡΠΏΠ΅ΡΠΈΠΌΠ΅Π½Ρ ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΠ»ΡΡ Ρ ΡΡΠ°ΡΡΠΈΠ΅ΠΌ ΠΎΠ΄Π½ΠΎΠΊΠΎΠΌΠΏΠΎΠ½Π΅Π½ΡΠ½ΡΡ
ΡΠΎΠ΅Π΄ΠΈΠ½Π΅Π½ΠΈΠΉ, ΡΠ°ΠΊΠΈΡ
ΠΊΠ°ΠΊ Si, Ge ΠΈ Π‘. ΠΡΠ΅Π½ΠΈΠ²Π°Π»ΠΈΡΡ ΡΠΊΠΎΡΠΎΡΡΡ ΠΏΠΎΠ»ΡΡΠ΅Π½ΠΈΡ ΡΠ½Π΅ΡΠ³ΠΈΠΈ Π²Π·Π°ΠΈΠΌΠΎΠ΄Π΅ΠΉΡΡΠ²ΡΡΡΠΈΡ
Π°ΡΠΎΠΌΠΎΠ², Π° ΡΠ°ΠΊΠΆΠ΅ ΡΠΎΡΠ½ΠΎΡΡΡ ΠΏΠΎΠ»ΡΡΠ΅Π½Π½ΠΎΠ³ΠΎ Π·Π½Π°ΡΠ΅Π½ΠΈΡ. Π₯Π°ΡΠ°ΠΊΡΠ΅ΡΠΈΡΡΠΈΠΊΠΈ ΡΠΊΠΎΡΠΎΡΡΠΈ ΠΈ ΡΠΎΡΠ½ΠΎΡΡΠΈ ΡΡΠ°Π²Π½ΠΈΠ²Π°Π»ΠΈΡΡ ΡΠΎ Π·Π½Π°ΡΠ΅Π½ΠΈΡΠΌΠΈ, ΠΏΠΎΠ»ΡΡΠ΅Π½Π½ΡΠΌΠΈ Ρ ΠΏΠΎΠΌΠΎΡΡΡ ΠΌΠ½ΠΎΠ³ΠΎΡΠ°ΡΡΠΈΡΠ½ΠΎΠ³ΠΎ ΠΏΠΎΡΠ΅Π½ΡΠΈΠ°Π»Π° ΠΌΠ΅ΠΆΠ°ΡΠΎΠΌΠ½ΠΎΠ³ΠΎ Π²Π·Π°ΠΈΠΌΠΎΠ΄Π΅ΠΉΡΡΠ²ΠΈΡ β ΠΏΠΎΡΠ΅Π½ΡΠΈΠ°Π»Π° Π’Π΅ΡΡΠΎΡΡΠ°.
Characteristics of Personal Value Motivational Sphere in Psychologists and Psychiatrists
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 Fisherβs 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 βeducationβ is more important for psychologists; the value of βtoleranceβ 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
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
ΠΠ½ΠΎΠ³ΠΎΠΌΠ°ΡΡΡΠ°Π±Π½ΠΎΠ΅ ΠΌΠΎΠ΄Π΅Π»ΠΈΡΠΎΠ²Π°Π½ΠΈΠ΅ ΠΊΠ»Π°ΡΡΠ΅ΡΠΎΠ² ΡΠΎΡΠ΅ΡΠ½ΡΡ Π΄Π΅ΡΠ΅ΠΊΡΠΎΠ² Π² ΠΏΠΎΠ»ΡΠΏΡΠΎΠ²ΠΎΠ΄Π½ΠΈΠΊΠΎΠ²ΡΡ ΡΡΡΡΠΊΡΡΡΠ°Ρ
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.ΠΠ»Π°ΡΡΠ΅ΡΡ ΡΠΎΡΠ΅ΡΠ½ΡΡ
ΠΈ ΠΏΡΠΎΡΡΠΆΠ΅Π½Π½ΡΡ
Π΄Π΅ΡΠ΅ΠΊΡΠΎΠ², Π²ΠΎΠ·Π½ΠΈΠΊΠ°ΡΡΠΈΠ΅ Π² ΠΏΠΎΠ»ΡΠΏΡΠΎΠ²ΠΎΠ΄Π½ΠΈΠΊΠ°Ρ
Π² ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠ΅ ΡΠ°Π΄ΠΈΠ°ΡΠΈΠΎΠ½Π½ΠΎΠ³ΠΎ Π²ΠΎΠ·Π΄Π΅ΠΉΡΡΠ²ΠΈΡ, ΠΏΠΎΠ·Π²ΠΎΠ»ΡΡΡ ΡΡΡΡΠΊΡΡΡΠ°ΠΌ ΠΏΡΠΈΠΎΠ±ΡΠ΅ΡΠ°ΡΡ ΡΠ°Π·Π»ΠΈΡΠ½ΡΠ΅ ΡΠ²ΠΎΠΉΡΡΠ²Π°, ΠΊΠΎΡΠΎΡΡΠ΅ ΠΌΠΎΠ³ΡΡ Π±ΡΡΡ ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½Ρ ΠΏΡΠΈ ΠΈΠ·Π³ΠΎΡΠΎΠ²Π»Π΅Π½ΠΈΠΈ ΠΏΡΠΈΠ±ΠΎΡΠΎΠ² Π½ΠΎΠ²ΠΎΠ³ΠΎ ΠΏΠΎΠΊΠΎΠ»Π΅Π½ΠΈΡ Π΄Π»Ρ Π½Π°Π½ΠΎΡΠ»Π΅ΠΊΡΠΎΠ½ΠΈΠΊΠΈ. Π§ΠΈΡΠ»Π΅Π½Π½ΠΎΠ΅ ΠΌΠΎΠ΄Π΅Π»ΠΈΡΠΎΠ²Π°Π½ΠΈΠ΅ ΠΏΠΎΠ»ΡΠΏΡΠΎΠ²ΠΎΠ΄Π½ΠΈΠΊΠΎΠ²ΡΡ
ΠΌΠ°ΡΠ΅ΡΠΈΠ°Π»ΠΎΠ², ΠΏΡΠΈΠΌΠ΅Π½ΡΠ΅ΠΌΠΎΠ΅ Π΄Π»Ρ ΠΈΠ·ΡΡΠ΅Π½ΠΈΡ ΡΠ°ΠΊΠΈΡ
ΠΏΡΠΎΡΠ΅ΡΡΠΎΠ², β ΡΡΠΎ ΡΠ΅ΡΡΡΡΠΎΠ΅ΠΌΠΊΠ°Ρ ΠΈ ΠΌΠ½ΠΎΠ³ΠΎΠ³ΡΠ°Π½Π°Ρ Π·Π°Π΄Π°ΡΠ°. ΠΠ»Ρ Π΅Π΅ ΡΠ΅ΡΠ΅Π½ΠΈΡ ΡΠΎΠ·Π΄Π°Π½ ΠΊΠΎΠΌΠΏΠ»Π΅ΠΊΡ ΠΌΠ½ΠΎΠ³ΠΎΠΌΠ°ΡΡΡΠ°Π±Π½ΠΎΠ³ΠΎ ΠΌΠΎΠ΄Π΅Π»ΠΈΡΠΎΠ²Π°Π½ΠΈΡ ΠΈ Π·Π°Π΄Π°Π½Π° ΠΌΠ½ΠΎΠ³ΠΎΠΌΠ°ΡΡΡΠ°Π±Π½Π°Ρ ΠΊΠΎΠΌΠΏΠΎΠ·ΠΈΡΠΈΡ, ΡΠΎΠ΄Π΅ΡΠΆΠ°ΡΠ°Ρ ΡΠΊΠ·Π΅ΠΌΠΏΠ»ΡΡΡ Π±Π°Π·ΠΎΠ²ΡΡ
ΠΌΠΎΠ΄Π΅Π»Π΅ΠΉ-ΠΊΠΎΠΌΠΏΠΎΠ·ΠΈΡΠΈΠΉ. Π Π°Π·ΡΠ°Π±ΠΎΡΠ°Π½ Π°Π»Π³ΠΎΡΠΈΡΠΌ, ΠΏΠΎΠ·Π²ΠΎΠ»ΡΡΡΠΈΠΉ ΡΡΠΊΠΎΡΡΡΡ ΡΠ°ΡΡΠ΅ΡΡ Π΄Π»Ρ ΡΠΈΡΡΠ΅ΠΌ Π±ΠΎΠ»ΡΡΠΈΡ
ΡΠ°Π·ΠΌΠ΅ΡΠ½ΠΎΡΡΠ΅ΠΉ ΠΈ ΡΡΠ΅ΡΠ° Π±ΠΎΠ»ΡΡΠΎΠ³ΠΎ ΠΊΠΎΠ»ΠΈΡΠ΅ΡΡΠ²Π° Π²Π·Π°ΠΈΠΌΠΎΠ΄Π΅ΠΉΡΡΠ²ΡΡΡΠΈΡ
Π°ΡΠΎΠΌΠΎΠ². Π ΠΊΠ°ΡΠ΅ΡΡΠ²Π΅ ΠΌΠΎΠ΄Π΅Π»ΠΈ ΡΠ°ΡΡΠΌΠΎΡΡΠ΅Π½Π° ΡΡΡΡΠΊΡΡΡΠ° ΠΊΡΠ΅ΠΌΠ½ΠΈΡ Ρ ΠΊΠΎΠΌΠΏΠ»Π΅ΠΊΡΠΎΠΌ ΡΠΎΡΠ΅ΡΠ½ΡΡ
Π΄Π΅ΡΠ΅ΠΊΡΠΎΠ². ΠΠΎΠ»Π΅ΠΊΡΠ»ΡΡΠ½ΠΎ-Π΄ΠΈΠ½Π°ΠΌΠΈΡΠ΅ΡΠΊΠΎΠ΅ ΠΌΠΎΠ΄Π΅Π»ΠΈΡΠΎΠ²Π°Π½ΠΈΠ΅ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΎ Ρ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½ΠΈΠ΅ΠΌ ΠΌΠ½ΠΎΠ³ΠΎΠΏΠ°ΡΠ°ΠΌΠ΅ΡΡΠΈΡΠ΅ΡΠΊΠΎΠ³ΠΎ ΠΏΠΎΡΠ΅Π½ΡΠΈΠ°Π»Π° Π’Π΅ΡΡΠΎΡΡΠ°. ΠΠ»Ρ ΡΠ°ΡΡΠ΅ΡΠΎΠ² ΠΏΡΠ΅Π΄ΡΡΠ°Π²Π»Π΅Π½ ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΡΠΉ ΠΏΠΎΠ΄Ρ
ΠΎΠ΄ ΠΊ ΠΎΡΡΡΠ΅ΡΡΠ²Π»Π΅Π½ΠΈΡ ΠΏΠ°ΡΠ°Π»Π»Π΅Π»ΡΠ½ΡΡ
Π²ΡΡΠΈΡΠ»Π΅Π½ΠΈΠΉ, ΠΈ ΠΏΡΠΈΠΌΠ΅Π½Π΅Π½Ρ ΠΏΡΠΎΠ³ΡΠ°ΠΌΠΌΠ½ΡΠ΅ ΡΡΠ΅Π΄ΡΡΠ²Π° ΡΠ°ΡΠΏΠ°ΡΠ°Π»Π»Π΅Π»ΠΈΠ²Π°Π½ΠΈΡ Π²ΡΡΠΈΡΠ»Π΅Π½ΠΈΠΉ, ΡΠ°Π·ΠΌΠ΅ΡΠ΅Π½Π½ΡΠ΅ Π½Π° Π³ΠΈΠ±ΡΠΈΠ΄Π½ΠΎΠΌ Π²ΡΡΠΎΠΊΠΎΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΠΈΡΠ΅Π»ΡΠ½ΠΎΠΌ Π²ΡΡΠΈΡΠ»ΠΈΡΠ΅Π»ΡΠ½ΠΎΠΌ ΠΊΠΎΠΌΠΏΠ»Π΅ΠΊΡΠ΅ Π€ΠΠ¦ Β«ΠΠ½ΡΠΎΡΠΌΠ°ΡΠΈΠΊΠ° ΠΈ ΡΠΏΡΠ°Π²Π»Π΅Π½ΠΈΠ΅Β» Π ΠΠ. ΠΠ»Ρ ΡΠ΅Π°Π»ΠΈΠ·Π°ΡΠΈΠΈ ΡΠ°ΡΠΏΠ°ΡΠ°Π»Π»Π΅Π»Π΅Π½Π½ΠΎΠ³ΠΎ Π°Π»Π³ΠΎΡΠΈΡΠΌΠ° ΠΈΡΠΏΠΎΠ»ΡΠ·ΠΎΠ²Π°Π½ ΡΡΠ°Π½Π΄Π°ΡΡ OpenMP. Π’Π°ΠΊΠΎΠΉ ΠΏΠΎΠ΄Ρ
ΠΎΠ΄ ΠΏΠΎΠ·Π²ΠΎΠ»ΠΈΠ» Π·Π½Π°ΡΠΈΡΠ΅Π»ΡΠ½ΠΎ ΡΠ½ΠΈΠ·ΠΈΡΡ Π²ΡΡΠΈΡΠ»ΠΈΡΠ΅Π»ΡΠ½ΡΡ ΡΠ»ΠΎΠΆΠ½ΠΎΡΡΡ ΠΏΡΠΎΠ²ΠΎΠ΄ΠΈΠΌΡΡ
ΡΠ°ΡΡΠ΅ΡΠΎΠ².ΠΠΎΠΊΠ°Π·Π°Π½ΠΎ, ΡΡΠΎ ΡΠ°Π·ΡΠ°Π±ΠΎΡΠ°Π½Π½ΠΎΠ΅ Π²ΡΡΠΎΠΊΠΎΠΏΡΠΎΠΈΠ·Π²ΠΎΠ΄ΠΈΡΠ΅Π»ΡΠ½ΠΎΠ΅ ΠΏΡΠΎΠ³ΡΠ°ΠΌΠΌΠ½ΠΎΠ΅ ΠΎΠ±Π΅ΡΠΏΠ΅ΡΠ΅Π½ΠΈΠ΅ ΠΌΠΎΠΆΠ΅Ρ Π·Π½Π°ΡΠΈΡΠ΅Π»ΡΠ½ΠΎ ΡΡΠΊΠΎΡΠΈΡΡ ΠΌΠΎΠ»Π΅ΠΊΡΠ»ΡΡΠ½ΠΎ-Π΄ΠΈΠ½Π°ΠΌΠΈΡΠ΅ΡΠΊΠΈΠ΅ ΡΠ°ΡΡΠ΅ΡΡ, Π² ΡΠ°ΡΡΠ½ΠΎΡΡΠΈ, ΡΠ°ΠΊΠΈΠ΅ ΠΊΠ°ΠΊ ΡΠ°ΡΡΠ΅Ρ ΡΠ½Π΅ΡΠ³ΠΈΠΈ ΡΠ²ΡΠ·ΠΈ Π΄ΠΈΠ²Π°ΠΊΠ°Π½ΡΠΈΠΉ Π·Π° ΡΡΠ΅Ρ Π°Π»Π³ΠΎΡΠΈΡΠΌΠ° ΡΠ°ΡΠΏΠ°ΡΠ°Π»Π»Π΅Π»ΠΈΠ²Π°Π½ΠΈΡ
Π Π΅ΠΊΠΎΠΌΠ΅Π½Π΄Π°ΡΠΈΠΈ ΠΏΠΎ ΠΏΡΠΎΠ³ΡΠ°ΠΌΠΌΠ΅ ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΡ ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² Π΄Π»Ρ Π»Π΅ΡΠ΅Π½ΠΈΡ Π³ΡΠΈΠΏΠΏΠ°
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.ΠΠΎΡΠ»Π΅Π΄ΡΡΠ²ΠΈΡ Π²ΡΠΏΡΡΠ΅ΠΊ ΡΠΏΠΈΠ΄Π΅ΠΌΠΈΠΉ Π³ΡΠΈΠΏΠΏΠ°, ΡΠ²ΡΠ·Π°Π½Π½ΡΡ
Ρ Π²ΡΡΠΎΠΊΠΎΠΊΠΎΠ½ΡΠ°Π³ΠΈΠΎΠ·Π½ΡΠΌ Ρ
Π°ΡΠ°ΠΊΡΠ΅ΡΠΎΠΌ ΠΈΠ½ΡΠ΅ΠΊΡΠΈΠΈ, Π° ΡΠ°ΠΊΠΆΠ΅ ΠΎΠ³ΡΠ°Π½ΠΈΡΠ΅Π½ΠΈΡ ΡΡΡΠ΅ΡΡΠ²ΡΡΡΠΈΡ
ΠΌΠ΅ΡΠΎΠ΄ΠΎΠ² Π»Π΅ΡΠ΅Π½ΠΈΡ ΠΈ Π²ΠΎΠ·Π½ΠΈΠΊΠ½ΠΎΠ²Π΅Π½ΠΈΠ΅ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΠΎΠΉ ΡΠ΅Π·ΠΈΡΡΠ΅Π½ΡΠ½ΠΎΡΡΠΈ ΠΎΠ±ΡΡΠ»Π°Π²Π»ΠΈΠ²Π°ΡΡ Π°ΠΊΡΡΠ°Π»ΡΠ½ΠΎΡΡΡ ΡΠ°Π·ΡΠ°Π±ΠΎΡΠΊΠΈ Π½ΠΎΠ²ΡΡ
Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² Π΄Π»Ρ Π»Π΅ΡΠ΅Π½ΠΈΡ ΡΡΠΎΠ³ΠΎ Π·Π°Π±ΠΎΠ»Π΅Π²Π°Π½ΠΈΡ. ΠΠ°Π΄Π»Π΅ΠΆΠ°ΡΠ΅Π΅ ΠΏΠ»Π°Π½ΠΈΡΠΎΠ²Π°Π½ΠΈΠ΅ ΠΏΡΠΎΠ³ΡΠ°ΠΌΠΌΡ ΠΈ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΠ΅ ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ, Π³Π°ΡΠ°Π½ΡΠΈΡΡΡΡΠΈΡ
ΠΏΠΎΠ»ΡΡΠ΅Π½ΠΈΠ΅ ΠΊΠΎΡΡΠ΅ΠΊΡΠ½ΡΡ
Π΄Π°Π½Π½ΡΡ
ΠΎΠ± ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΠΈ Π±Π΅Π·ΠΎΠΏΠ°ΡΠ½ΠΎΡΡΠΈ ΡΠ°Π·ΡΠ°Π±Π°ΡΡΠ²Π°Π΅ΠΌΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ², ΠΎΠ±Π΅ΡΠΏΠ΅ΡΠΈΠ²Π°Π΅ΡΡΡ ΡΠΎΠ±Π»ΡΠ΄Π΅Π½ΠΈΠ΅ΠΌ ΡΠ΅ΠΊΠΎΠΌΠ΅Π½Π΄Π°ΡΠΈΠΉ ΡΠ΅Π³ΡΠ»ΡΡΠΎΡΠ½ΡΡ
ΠΎΡΠ³Π°Π½ΠΎΠ². ΠΠ° Π΄Π°Π½Π½ΡΠΉ ΠΌΠΎΠΌΠ΅Π½Ρ Π² Π ΠΎΡΡΠΈΠΉΡΠΊΠΎΠΉ Π€Π΅Π΄Π΅ΡΠ°ΡΠΈΠΈ ΠΈ ΠΠ²ΡΠ°Π·ΠΈΠΉΡΠΊΠΎΠΌ ΡΠΊΠΎΠ½ΠΎΠΌΠΈΡΠ΅ΡΠΊΠΎΠΌ ΡΠΎΡΠ·Π΅ ΠΎΡΡΡΡΡΡΠ²ΡΡΡ Π΄ΠΎΠΊΡΠΌΠ΅Π½ΡΡ, ΡΠΎΠ΄Π΅ΡΠΆΠ°ΡΠΈΠ΅ ΡΠ΅ΠΊΠΎΠΌΠ΅Π½Π΄Π°ΡΠΈΠΈ ΠΏΠΎ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΡ ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ ΠΏΡΠΎΡΠΈΠ²ΠΎΠ³ΡΠΈΠΏΠΏΠΎΠ·Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ². Π‘ΡΡΠ΅ΡΡΠ²ΡΠ΅Ρ ΠΏΠΎΡΡΠ΅Π±Π½ΠΎΡΡΡ Π² ΡΠ°Π·ΡΠ°Π±ΠΎΡΠΊΠ΅ ΠΎΡΠ΅ΡΠ΅ΡΡΠ²Π΅Π½Π½ΠΎΠ³ΠΎ ΡΡΠΊΠΎΠ²ΠΎΠ΄ΡΡΠ²Π°, ΠΎΡΡΠ°ΠΆΠ°ΡΡΠ΅Π³ΠΎ ΠΏΠΎΡΡΠ΄ΠΎΠΊ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΡ ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ, Π° ΡΠ°ΠΊΠΆΠ΅ ΡΠ΅Π³Π»Π°ΠΌΠ΅Π½ΡΠΈΡΡΡΡΠ΅Π³ΠΎ Π½Π΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΡΠΉ ΠΎΠ±ΡΠ΅ΠΌ Π΄Π°Π½Π½ΡΡ
, ΠΊΠΎΡΠΎΡΡΠ΅ Π΄ΠΎΠ»ΠΆΠ½Ρ Π±ΡΡΡ ΠΏΡΠ΅Π΄ΡΡΠ°Π²Π»Π΅Π½Ρ ΠΏΡΠΈ ΡΠ΅Π³ΠΈΡΡΡΠ°ΡΠΈΠΈ Π½ΠΎΠ²ΡΡ
ΠΏΡΠΎΡΠΈΠ²ΠΎΠ³ΡΠΈΠΏΠΏΠΎΠ·Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ². Π¦Π΅Π»Ρ ΡΠ°Π±ΠΎΡΡ β ΠΈΠ·ΡΡΠ΅Π½ΠΈΠ΅ ΠΎΡΠ½ΠΎΠ²Π½ΡΡ
Π²ΠΎΠ·ΠΌΠΎΠΆΠ½ΡΡ
ΡΠ΅Π³ΡΠ»ΡΡΠΎΡΠ½ΡΡ
ΠΏΠΎΠ΄Ρ
ΠΎΠ΄ΠΎΠ² ΠΊ ΠΏΠ»Π°Π½ΠΈΡΠΎΠ²Π°Π½ΠΈΡ ΠΏΡΠΎΠ³ΡΠ°ΠΌΠΌ ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² Π΄Π»Ρ Π»Π΅ΡΠ΅Π½ΠΈΡ Π³ΡΠΈΠΏΠΏΠ°. ΠΡΠΎΠ±ΠΎΠ΅ Π²Π½ΠΈΠΌΠ°Π½ΠΈΠ΅ ΡΠ΄Π΅Π»Π΅Π½ΠΎ ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΠΌ ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΡΠΌ III ΡΠ°Π·Ρ ΠΊΠ°ΠΊ ΠΎΡΠ½ΠΎΠ²Π½ΡΠΌ ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΡΠΌ, ΠΏΠΎΠ΄ΡΠ²Π΅ΡΠΆΠ΄Π°ΡΡΠΈΠΌ ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΡ ΠΈ Π±Π΅Π·ΠΎΠΏΠ°ΡΠ½ΠΎΡΡΡ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ°. ΠΠΏΠΈΡΠ°Π½Π° ΡΡΡΠ°ΡΠ΅Π³ΠΈΡ ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠ°, ΡΡΠ΅Π±ΠΎΠ²Π°Π½ΠΈΡ ΠΊ ΠΎΠ±ΡΠ΅ΠΌΡ ΠΈ ΠΊΠ°ΡΠ΅ΡΡΠ²Ρ Π΄Π°Π½Π½ΡΡ
ΠΏΠΎ ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΠΎΡΡΠΈ ΠΈ Π±Π΅Π·ΠΎΠΏΠ°ΡΠ½ΠΎΡΡΠΈ. ΠΠ°ΡΠ΅ΡΠΈΠ°Π» ΠΏΠΎΠ΄Π³ΠΎΡΠΎΠ²Π»Π΅Π½ Π½Π° ΠΎΡΠ½ΠΎΠ²Π΅ Π΄Π΅ΠΉΡΡΠ²ΡΡΡΠΈΡ
ΡΠ΅ΠΊΠΎΠΌΠ΅Π½Π΄Π°ΡΠΈΠΉ ΠΊ ΠΏΠ»Π°Π½ΠΈΡΠΎΠ²Π°Π½ΠΈΡ ΠΈ ΡΠ°Π·ΡΠ°Π±ΠΎΡΠΊΠ΅ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ
ΡΡΠ΅Π΄ΡΡΠ² Π² Π ΠΎΡΡΠΈΠΉΡΠΊΠΎΠΉ Π€Π΅Π΄Π΅ΡΠ°ΡΠΈΠΈ, ΡΡΠΊΠΎΠ²ΠΎΠ΄ΡΡΠ²Π° ΠΏΠΎ ΡΠΊΡΠΏΠ΅ΡΡΠΈΠ·Π΅ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ
ΡΡΠ΅Π΄ΡΡΠ² ΠΈ ΡΠ΅ΠΊΠΎΠΌΠ΅Π½Π΄Π°ΡΠΈΠΉ Π£ΠΏΡΠ°Π²Π»Π΅Π½ΠΈΡ ΠΏΠΎ ΠΊΠΎΠ½ΡΡΠΎΠ»Ρ Π·Π° ΠΊΠ°ΡΠ΅ΡΡΠ²ΠΎΠΌ ΠΏΡΠΎΠ΄ΡΠΊΡΠΎΠ² ΠΏΠΈΡΠ°Π½ΠΈΡ ΠΈ Π»Π΅ΠΊΠ°ΡΡΡΠ²Π΅Π½Π½ΡΡ
ΡΡΠ΅Π΄ΡΡΠ² Π‘Π¨Π. Π ΡΠ΅Π·ΡΠ»ΡΡΠ°ΡΠ΅ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½Π½ΠΎΠ³ΠΎ Π°Π½Π°Π»ΠΈΠ·Π° ΠΏΠΎΠΊΠ°Π·Π°Π½Π° Π½Π΅ΠΎΠ±Ρ
ΠΎΠ΄ΠΈΠΌΠΎΡΡΡ ΡΠ°Π·ΡΠ°Π±ΠΎΡΠΊΠΈ ΠΎΡΠ΅ΡΠ΅ΡΡΠ²Π΅Π½Π½ΡΡ
ΡΠ΅ΠΊΠΎΠΌΠ΅Π½Π΄Π°ΡΠΈΠΉ ΠΏΠΎ ΠΏΡΠΎΠ²Π΅Π΄Π΅Π½ΠΈΡ ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΈΡ
ΠΈΡΡΠ»Π΅Π΄ΠΎΠ²Π°Π½ΠΈΠΉ ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² Π΄Π»Ρ Π»Π΅ΡΠ΅Π½ΠΈΡ Π³ΡΠΈΠΏΠΏΠ° Ρ ΡΡΠ΅ΡΠΎΠΌ ΡΠΏΠ΅ΡΠΈΡΠΈΠΊΠΈ ΡΡΠΈΠ΄ΠΈΡΠ΅ΡΠΊΠΈΡ
Π½ΠΎΡΠΌ ΠΈ ΡΡΠ°Π΄ΠΈΡΠΈΠΉ ΡΠΎΡΡΠΈΠΉΡΠΊΠΎΠΉ ΠΊΠ»ΠΈΠ½ΠΈΡΠ΅ΡΠΊΠΎΠΉ ΠΏΡΠ°ΠΊΡΠΈΠΊΠΈ. Π Π°Π·ΡΠ°Π±ΠΎΡΠΊΠ° ΡΠ°ΠΊΠΈΡ
ΡΠ΅ΠΊΠΎΠΌΠ΅Π½Π΄Π°ΡΠΈΠΉ ΠΏΡΠΈΠ²Π΅Π΄Π΅Ρ ΠΊ ΡΡΠΊΠΎΡΠ΅Π½ΠΈΡ Π²Π²ΠΎΠ΄Π° Π² ΠΏΡΠ°ΠΊΡΠΈΠΊΡ Π½ΠΎΠ²ΡΡ
ΡΡΡΠ΅ΠΊΡΠΈΠ²Π½ΡΡ
ΠΏΡΠ΅ΠΏΠ°ΡΠ°ΡΠΎΠ² ΠΏΡΠΎΡΠΈΠ² Π³ΡΠΈΠΏΠΏΠ°
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