Estimating turbulent velocities in the elliptical galaxies NGC 5044 and NGC 5813

The interstellar and intra-cluster medium in giant elliptical galaxies and clusters of galaxies is often assumed to be in hydrostatic equilibrium. Numerical simulations, however, show that about 5-30% of the pressure in a cluster is provided by turbulence induced by, for example, the central AGN and merger activity. We aim to put constraints on the turbulent velocities and turbulent pressure in the ICM of the giant elliptical galaxies NGC 5044 and NGC 5813 using XMM-Newton RGS observations. The magnitude of the turbulence is estimated using the Fe XVII lines at 15.01 A, 17.05 A, and 17.10 A in the RGS spectra. At low turbulent velocities, the gas becomes optically thick in the 15.01 A line due to resonant scattering, while the 17 A lines remain optically thin. By comparing the (I(17.05)+I(17.10))/I(15.01) line ratio from RGS with simulated line ratios for different Mach numbers, the level of turbulence is constrained. The measurement is limited by systematic uncertainties in the atomic data, which are at the 20-30% level. We find that the line ratio in NGC 5813 is significantly higher than in NGC 5044. This difference can be explained by a higher level of turbulence in NGC 5044. The high turbulent velocities and the fraction of the turbulent pressure support of >40% in NGC 5044, assuming isotropic turbulence, confirm that it is a highly disturbed system, probably due to an off-axis merger. The turbulent pressure support in NGC 5813 is more modest at 15-45%. The (I(17.05)+I(17.10))/I(15.01) line ratio in an optically thin plasma, calculated using AtomDB v2.0.1, is 2 sigma above the ratio measured in NGC 5044, which cannot be explained by resonant scattering. This shows that the discrepancies between theoretical, laboratory, and astrophysical data on Fe XVII lines need to be reduced to improve the accuracy of the determination of turbulent velocities using resonant scattering.Comment: 11 pages, 5 figures, accepted for publication in A&

Analysis of Noncompliances with Legislative Requirements in Pharmacovigilance Materials of Registration Dossiers

Since 1 January 2021 the authorisation of medicines in the Russian Federation has to be performed according to the Eurasian Economic Union (EAEU) procedure. The Pharmacovigilance System Master File (PSMF) is the main document describing the pharmacovigilance system of the marketing authorisation holder (MAH) or its authorised representative.  The aim of the study was to analyse noncompliances with the EAEU requirements, which were revealed during PSMF assessment.Materials and methods: the authors analysed 687 pharmacovigilance documents included in registration dossiers that were submitted for assessment from 1 January to 30 June, 2021.  Results: the authors identified and systematised the main noncompliances with the EAEU requirements in terms of presentation, content, completeness of each PSMF section. They analysed the frequency of noncompliances in PSMFs and identified the most frequent flaws of MAHs’ pharmacovigilance systems.Conclusions: the authors give recommendations for elimination of significant noncompliances identified during PSMF assessment, which may include: timely updating, maintenance, and revision of the documents in accordance with changes in legislation and any other significant changes, regular training of pharmacovigilance staff, etc. The results of this review will be useful for MAHs as the main participants of the marketing authorisation process who are directly involved in the pharmacovigilance system management at the pre- and post-authorisation stages, and will help them prevent potential mistakes when drawing up pharmacovigilance system documents

Pharmacovigilance System Master File: An Overview of Changes in the EAEU Good Pharmacovigilance Practice

The development of international regulatory practices and the accumulation of new experience in pharmacovigi­lance prompted the need to amend the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP Guideline), first adopted in 2016.The aim of the study was to review, from a regulatory expert’s perspective, the changes to the structure and presentation of the pharmacovigilance system master file (PSMF) introduced with the amendment of the EAEU GVP Guideline effective since December 6, 2022.The authors compared the requirements for the PSMF outlined in the new edition of the EAEU GVP Guideline adopted by Decision No.81 of the Council of the Eurasian Economic Commission of 19.06.2022 “On Amendments to the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union” with the requirements described in the previous version of this document.The structure and content of Module III, Pharmacovigilance System Master File, have been significantly amended in the new version of the EAEU GVP Guideline; this will require marketing authorisation holders (MAHs) to revise the PSMFs describing pharmacovigilance system data. The most significant editorial changes have been made to the paragraphs concerning the PSMF format, the pharmacovigilance quality system, and the presentation of information in the Annexes. The amendment has strengthened the control of records and documentation related to the pharmacovigilance system. Electronic PSMFs are acceptable; electronic book-marking and searchable text make working with the PSMF more convenient for representatives of MAHs and experts of regulatory authorities. Aligning of the PSMF with the requirements of the new edition of the EAEU GVP Guideline will contribute to improving the pharmacovigilance system operation and performance

Professional satisfaction of doctors-pediatricians six months later of independent medical practice

The medical profession has a long history. While modern medicine has little in common with mystical rituals of the ancient world, the role of the doctor remained unchanged. The success of therapeutic effects, primarily determined by the appearance of the doctor, whose professional activity is fundamentally different from that of any other professional. On the professional development of the individual is largely influenced by the early years of operation, since this period is considered to be the “trial period”, which further establishes the position of the expert in social and professional environment is the foundation for his future professional career, which will largely determine its success.Профессия врача имеет многолетнюю историю. Хотя и современная медицина уже мало напоминает мистические ритуалы Древнего мира, роль врача осталась неизменной. Успех лечебного воздействия, в первую очередь, определяется обликом врача, профессиональная деятельность которого коренным образом отличается от деятельности любого другого специалиста. На профессиональное развитие личности в значительной степени влияют первые годы работы, поскольку именно этот период считается тем «испытательным сроком», который в дальнейшем устанавливает позиции специалиста в социальной и профессиональной среде, является фундаментом для его будущей профессиональной карьеры, который во многом будет определять ее успешность

Professional satisfaction of doctors-pediatricians six months later of independent medical practice

The profession of the doctor has long-term history. Though the modern medicine already reminds mystical rituals of the Ancient world a little, the role of the doctor remained invariable. Success of medical influence, first of all, is defined by shape of the doctor which professional activity radically differs from activity of any other expert. Professional development of the personality is influenced substantially by the first years of work as this period is considered that “trial period” which establishes further the expert’s positions in the social and professional environment, is the base for his future professional career which will define in many respects her success.Профессия врача имеет многолетнюю историю. Хотя и современная медицина уже мало напоминает мистические ритуалы Древнего мира, роль врача осталась неизменной. Успех лечебного воздействия, в первую очередь, определяется обликом врача, профессиональная деятельность которого коренным образом отличается от деятельности любого другого специалиста. На профессиональное развитие личности в значительной степени влияют первые годы работы, поскольку именно этот период считается тем «испытательным сроком», который в дальнейшем устанавливает позиции специалиста в социальной и профессиональной среде, является фундаментом для его будущей профессиональной карьеры, который во многом будет определять ее успешность

Диагностическое значение определения поверхностных антигенов лимфоцитов у больных атопической бронхиальной астмой (опыт использования моноклональных антител серии ЛТ)

The determination of surfase lymphocyte antigens in patients with atopic bronchial asthma has been carried out using the monoclonal antibodies of the home series LT. The examined patients have been found to have some disorders of the expression antigens under investigation on immunoregulating cells. These disorders are more strongly marked during acute periods of the disease. The decrease of the expression of CD8 antigen is typical of bronchial asthma patients, the amount of CD8+ lymphocytes being 15,6=b0,3 % in the acute period and 17,04hl,8 % during period of remission against 23,84=0,6 % in healthy donors.The results obtained confirm the opinion about insufficiency of supressor T-lymphocytes in the cases of atopic bronchial asthma and enable to recommend the determination of surface lymphocyte antigens as one of the immunological criteria when this disease takes play.

Comparative Dissolution Kinetics of Several Multisource Thioctic Acid Products

The relationship between dissolution and bioavailability is an example of the interdependency between the quality of a medicinal product and its safety and efficacy. The uniqueness of thioctic acid is that it can exist in an oxidised and a reduced form, showing lipophilic (lipoic acid) and hydrophilic (dihydrolipoic acid) properties. Bioavailability studies of thioctic acid are necessary to evaluate the expected therapeutic effect and mitigate side effects of the medicinal product.The aim of the study was to carry out equivalence dissolution testing to compare the release of thioctic acid from medicinal products produced by several manufacturers.Materials and methods: the study used a reference medicinal product and three multisource medicinal products by different manufacturers; more specifically, film-coated tablets containing 600 mg of thioctic acid. The experiment was carried out in dissolution media at pH of 6.8±0.05 and 1.2±0.05. Statistical analysis was performed by calculating the average amounts of the substance dissolved, the standard deviation (SD), and the relative standard deviation (RSD, %) using Microsoft Office Excel 2007.Results: The authors chose the testing conditions (dissolution media pH values of 6.8±0.05 and 1.2±0.05) taking into account the nature and characteristics of thioctic acid. The comparison of thioctic acid release profiles based on the calculation of the similarity factor (f2) showed that the dissolution profiles of multisource medicinal products 2 and 3 at pH 6.8 were equivalent to that of the reference medicinal product (more than 85% of the active pharmaceutical ingredient released within 15 minutes) and the dissolution profile of multisource medicinal product 1 was not equivalent to it (with f2 of 28).Conclusions: the established differences in the rate and degree of active ingredient release from the studied medicinal products may indicate possible differences in their pharmacological effectiveness in vivo

Safety of Antibacterial and Antiprotozoal Medicinal Products

The experts of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of foreign regulatory authorities on the recalls of antibacterial and antiprotozoal medicinal products and/or the need for labelling updates due to changes in the safety profile. The analysis revealed 16 decisions containing information on the following medicines registered in Russia: ertapenem, сeftriaxone, cefazolin, аmoxicillin, сefoperazone+sulbactam, piperacillin+tazobactam, сlindamycin, teicoplanin, rifampin, co-trimoxazole, hydroxychloroquine