Safety Authority Research Articles

Biological Approaches to Bone Regeneration: Innovations and Clinical Implications

In orthopaedics, bone regeneration is still a major difficulty that calls for creative solutions for efficient tissue repair. Modern biological techniques, such as scaffolds, growth factors, tissue engineering, and their therapeutic applications in bone regeneration, are examined in this study. Growth factors—in particular, platelet-derived growth factors (PDGFs) and bone morphogenetic proteins (BMPs)—are essential for promoting osteogenesis and improving bone regeneration. Clinical settings have shown their therapeutic potential; nonetheless, there are ideal doses, administration modalities, and safety profiles to take into account. With their exact designs and variety of biomaterials, scaffolds provide structural support and foster the cellular activity that is essential for bone repair. The functioning and interactions between cells and scaffolds are improved by a variety of manufacturing approaches, including 3D bioprinting and surface changes. Tissue engineering techniques combine scaffolds, cells, and signalling molecules to create useful tissue constructions for bone mending. In tissue-engineered structures, the integration of growth factors and mesenchymal stem cells (MSCs) exhibit potential for augmenting osteogenesis. Clinical applications provide a variety of settings for regenerative therapies, including fracture healing, non-unions, and significant bone defects. However, obstacles to their wider clinical application include safety assurance, scalability, regulatory compliance, effectiveness validation, and personalised therapy. By tackling these obstacles with thorough investigation and translational work, novel biological strategies to improve bone regeneration treatments will become possible.

Magistral Phage Preparations: Is This the Model for Everyone?

Phage therapy is increasingly put forward as a promising additional tool to help curb the global antimicrobial resistance crisis. However, industrially manufactured phage medicinal products are currently not available on the European Union and United States markets. In addition, it is expected that the business purpose-driven phage products that are supposed to be marketed in the future would mainly target commercially viable bacterial species and clinical indications, using fixed phage cocktails. hospitals or phage therapy centers aiming to help all patients with difficult-to-treat infections urgently need adequate phage preparations. We believe that national solutions based on the magistral preparation of personalized (preadapted) phage products by hospital and academic facilities could bring an immediate solution and could complement future industrially manufactured products. Moreover, these unlicensed phage preparations are presumed to be more efficient and to elicit less bacterial phage resistance issues than fixed phage cocktails, claims that need to be scientifically substantiated as soon as possible. Just like Belgium, other (European) countries could develop a magistral phage preparation framework that would exist next to the conventional medicinal product development and licensing pathways. However, it is important that the current producers of personalized phage products are provided with pragmatic quality and safety assurance requirements, which are preferably standardized (at least at the European level), and are tiered based on benefit-risk assessments at the individual patient level. Pro bono phage therapy providers should be supported and not stopped by the imposition of industry standards such as Good Manufacturing Practice requirements. Keywords: antimicrobial resistance; antibiotic resistance; bacterial infection; bacteriophage therapy; magistral preparation.

Bioevaluation of spiro N-propargylic β-enaminones as anti-breast cancer agents: Cell cycle and molecular docking studies.

The study aimed to investigate the in vitro inhibitory activities of spiro N-propargylic β-enaminones (SPEs) (1-31) against breast cancer cells (BCa). Cytotoxic activity was investigated via MTT assay. DNA fragmentation was evaluated via ELISA assay. Cell cycle distributions were investigated by flow cytometry. Expression levels of Bcl-2, Bax, p21 and Cyclin D1 were measured by qRT-PCR and western blot analysis. Autodock/vina software was used to understand the interaction between the SPEs and the ERα, PR, EGFR, and Her2. ADMETlab 2.0 tool was used to determine the drug-likeness properties. Notably, SPEs 1, 22, and 28 displayed selective cytotoxicity and apoptosis against BCa cells. They arrested the cell cycle at the S phase, inducing p21 and Cyclin D1. SPE1, SPE22, and SPE28 exhibited strong affinity for BCa receptors and drug-like properties. Pending in vivo validation with safety assurance for human health, these compounds hold potential as chemotherapy candidates.

SiRENE: A new generation of engineering simulator for real-time simulators at EDF

For Safety Assisted Engineering works, real-time simulators have emerged as a mandatory tool among all the key actors involved in the nuclear industry (utilities, designers and safety authorities). EDF, Electricité de France, as the leading worldwide nuclear power plant operator, has a crucial need for efficient and updated simulation tools for training, operating and safety analysis support.This paper will present the work performed at EDF/DT to develop a new generation of engineering simulator to fulfil these tasks. The project is called SiRENE, which is the acronym of Re-hosted Engineering Simulator in French. The project has been economically challenging. Therefore, to benefit from existing tools and experience, the SiRENE project combines:- A part of the process issued from the operating fleet training full-scope simulator.- An improvement of the simulator prediction reliability with the integration of High-Fidelity models, used in Safety Analysis. These High-Fidelity models address Nuclear Steam Supply System code, with CATHARE thermal-hydraulics system code and neutronics, with COCCINELLE code.- And taking advantage of the last generation and improvements of instructor station.The intensive and challenging uses of the new SiRENE engineering simulator are also discussed. The SiRENE simulator has to address different topics such as verification and validation of operating procedures, identification of safety paths, tests of I&C developments or modifications, tests on hydraulics system components (pump, valve etc.), support studies for Probabilistic Safety Analysis (PSA). etc. It also emerges that SiRENE simulator is a valuable tool for self-training of the newcomers in EDF nuclear engineering centers.As a modifiable tool and thanks to a skillful team managing the SiRENE project, specific and adapted modifications can be taken into account very quickly, in order to provide the best answers for our users' specific issues.Finally, the SiRENE simulator, and the associated configurations, has been distributed among the different engineering centers at EDF (DT in Lyon, DIPDE in Marseille and CNEPE in Tours). This distribution highlights a strong synergy and complementarity of the different engineering institutes at EDF, working together for a safer and a more profitable operating fleet.

Safety assurance assessment of palmito cheese: A Mesoamerican pasta filata unripe artisanal cheese

Use of acidification and kneading/stretching steps to ensure the safety of palmito cheese was evaluated. The pH (acidification) and temperature (kneading/stretching) kinetics were recorded during processing for three cheese batches from each of three artisanal producers and a pilot plant-produced cheese. The pH and water activity of cheeses were used to estimate the growth potential of pathogens of concern. F65 °C equivalent values for Coxiella burnetii were calculated using temperature kinetics. Theoretical logarithmic reductions for other foodborne pathogens were also estimated based on D and z values reported in literature. According to their pH and water activity, all produced cheeses may support the growth of Listeria monocytogenes, Salmonella, Escherichia coli O157:H7, and Staphylococcus aureus. Calculated F65 °C values for C. burnetii confirmed that the kneading/stretching operation cannot substitute milk pasteurisation. In no case was a 5-log reduction of all pathogens achieved. Hence, both steps should not be used as sole safety-assuring hurdles.

Experimental Study on Optimum Design of Aircraft Icing Detection Based on Large-Scale Icing Wind Tunnel

Icing detection is the premise and basis for the operation of aircraft icing protection system, and is the primary issue in flight safety assurance. At present, there is a lack of research methods and design reference for the layout optimization of ice detectors. Therefore, in order to simulate the real icing environment encountered by the aircraft more accurately, a large-scale icing wind tunnel was used to carry out experimental research on the icing characteristics of the sensor probes. A closed-loop experimental method including the typical condition selection, sensor array interference examination and ice shape repeatability verification was initially proposed. A stepwise optimization process and a sensitivity analysis on ambient conditions were combined to determine the optimal distribution for sensor installation. It is found that the water collection coefficient on the cylinder surface of the probe first increases and then decreases along the axial direction, reaching the extreme value at a certain position. The height of this extreme point will gradually increase with the development of the wall boundary layer, showing a variation range of 2~30 mm. Improper design may cause the sensor probe to fail to capture the point with the maximum icing thickness, affecting the sensitivity of icing detection. In addition, each probe position has different sensitivity to changes in flow parameters; the points with larger icing mass and lower sensitivity to changes in attack angle will have better detection effect. The measured data and analysis in the present work can provide a basis for the accurate design of icing sensor probes.

Data-driven rapid lifetime prediction method for lithium-ion batteries under diverse fast charging protocols

Accurate lithium-ion battery lifetime prediction is essential for equipment maintenance and safety assurance in practical applications. The influence of different charge protocols on the lifetime varies greatly, which raises tremendous challenges for rapid lifetime prediction. In this paper, a comprehensive data-driven rapid lifetime prediction method for batteries under diverse fast charging protocols is proposed. It straightforwardly establishes the relationship between the charging conditions and the impacts on battery lifetime. A deep neural network model with the Bayesian optimization algorithm for hyperparameter search (BOA-DNN) and three traditional shallow machine learning algorithms consisting of support vector machine (SVM), Gaussian process regression (GPR), and extreme gradient boosting (XGBoost) are employed. The verification is performed on an authoritative and popular dataset with 69 types of distinct fast charging conditions. The eventual results indicate that the proposed approach has attained reliable performance of battery lifetime degradation trajectory and battery end-of-life (EOL) prediction, in which the BOA-DNN model outperforms SVM, GPR, and XGBoost. Especially in battery EOL prediction, the prediction mean absolute percentage error of the BOA-DNN model is below 3.58%.

Microplastics in Orthodontics

Introduction :The role of microplastics in the environment have become a major concern over the years .the leaching of microplastics from the materials used in the orthodontics has been increased .primary and secondary microplastics are leached from the materials such as tooth paste, retainers , resin-based composite and aligners. Microplastics and nano plastics are small plastic fragments of <5 mm and <1000 nm, respectively. Most commonly, MPs are defined as synthetic polymer particles or fibers with a diameter of 1–5000 μm , even though the lower limit has been extended down to 100 nm by the European Food and Safety Authority (EFSA). Their ingestion could cause oxidative stress and inflammatory lesions. Thus, it is important to enhance the understanding of microplastics to minimise the potential risks.

Food chain information for pigs in Europe: A study on the status quo, the applicability and suggestions for improvements

Food chain information (FCI) as stated in Regulation (EC) No 853/2004 plays a vital role in supporting decision-making and guiding of risk managers at abattoirs by providing valuable insights into inspection methods and intensity. However, the lack of specific guidelines on data collection within FCI presents a challenge. To address this issue, we conducted an online survey among stakeholders in the European pig industry to assess the current state of FCI implementation and identify areas for improvement. Out of the 93 respondents, over 50% reported they had access to data on ante- and post-mortem findings as well as on treatments with withdrawal periods during the fattening period. Additionally, 49% had access to data on veterinary medicinal products (VMPs) administered to the pigs. Despite the mandatory nature of this data according to Regulation (EC) No 853/2004, our findings revealed a lack of legally required information in the transmission of FCI. When evaluating the usefulness of FCI in food safety decision-making, 60% of the respondents found it helpful, while 40% expressed varying levels of dissatisfaction with the currently available FCI. These results highlight the current challenges in the implementation of FCI for pigs in Europe. Furthermore, our study identified a significant correlation between the assessment of FCI usefulness and access to animal health data and additional information on abnormalities. We also identified research gaps in establishing critical thresholds for mortality rate and determining the relevant period for VMP documentation. To enhance the FCI system and improve animal health and food safety, management, comprehensive legislation and technical implementations for data exchange are crucial. Close collaboration among stakeholders, stakeholder training, development of abattoir-specific strategies and integration of harmonised epidemiological indicators into FCI are recommended. In conclusion, clear specifications regarding the necessary data for FCI are vital as FCI plays an integral role in the risk-based meat safety assurance system. Implementing these recommendations will enhance the effectiveness of FCI, improve decision-making processes and strengthen the overall food safety management.

A Database Extension for a Safety Evaluation of a Hydrogen Refueling Station with a Barrier Using a CFD Analysis and a Machine Learning Method

A methodology is proposed to extend datasets in a database suitable for use as a reference tool to support an evaluation of damage mitigation by a barrier wall in a hydrogen refueling station (HRS) during a vapor cloud explosion (VCE) accident. This is realized with a computational fluid dynamic (CFD) analysis and machine learning (ML) technology because measured data from hydrogen explosion tests with various installed barrier models usually require considerable amounts of time, a secured space, and precise measurements. A CFD sensitivity calculation was conducted using the radXiFoam v1.0 code and the established analysis methodology with an error range of approximately ±30% while changing the barrier height from that was used in an experiment conducted by the Stanford Research Institute (SRI) to investigate the effect of the barrier height on the reduction in peak overpressures from an explosion site to far fields in an open space. The radXiFoam code was developed based on the open-source CFD software OpenFOAM-v2112 to simulate a VCE accident in a humid air environment at a compressed gaseous or liquefied HRS. We attempted to extend the number of datasets in the VCE database through the use of the ML method on the basis of pressure data predicted by a CFD sensitivity calculation, also uncovering the possibility of utilizing the ML method to extend the VCE database. The data produced by the CFD sensitivity calculation and the ML method will be examined to confirm their validity and applicability to hypothetical VCE accident simulations if the related test data can be produced during experimental research. The database constructed using core data from the experiment and extended data from the CFD analysis and the ML method will be used to increase the credibility of radXiFoam analysis results for VCE accident scenarios at HRSs, ultimately contributing to safety assurances of HRSs in Republic of Korea.

Chitooligosaccharide and Its Derivatives: Potential Candidates as Food Additives and Bioactive Components.

Chitooligosaccharide (CHOS), a depolymerized chitosan, can be prepared via physical, chemical, and enzymatic hydrolysis, or a combination of these techniques. The superior properties of CHOS have attracted attention as alternative additives or bioactive compounds for various food and biomedical applications. To increase the bioactivities of a CHOS, its derivatives have been prepared via different methods and were characterized using various analytical methods including FTIR and NMR spectroscopy. CHOS derivatives such as carboxylated CHOS, quaternized CHOS, and others showed their potential as potent anti-inflammatory, anti-obesity, neuroprotective, and anti-cancer agents, which could further be used for human health benefits. Moreover, enhanced antibacterial and antioxidant bioactivities, especially for a CHOS-polyphenol conjugate, could play a profound role in shelf-life extension and the safety assurance of perishable foods via the inhibition of spoilage microorganisms and pathogens and lipid oxidation. Also, the effectiveness of CHOS derivatives for shelf-life extension can be augmented when used in combination with other preservative technologies. Therefore, this review provides an overview of the production of a CHOS and its derivatives, as well as their potential applications in food as either additives or nutraceuticals. Furthermore, it revisits recent advancements in translational research and in vivo studies on CHOS and its derivatives in the medical-related field.

Uncertainty quantification in machine learning for engineering design and health prognostics: A tutorial

On top of machine learning (ML) models, uncertainty quantification (UQ) functions as an essential layer of safety assurance that could lead to more principled decision making by enabling sound risk assessment and management. The safety and reliability improvement of ML models empowered by UQ has the potential to significantly facilitate the broad adoption of ML solutions in high-stakes decision settings, such as healthcare, manufacturing, and aviation, to name a few. In this tutorial, we aim to provide a holistic lens on emerging UQ methods for ML models with a particular focus on neural networks and the applications of these UQ methods in tackling engineering design as well as prognostics and health management problems. Towards this goal, we start with a comprehensive classification of uncertainty types, sources, and causes pertaining to UQ of ML models. Next, we provide a tutorial-style description of several state-of-the-art UQ methods: Gaussian process regression, Bayesian neural network, neural network ensemble, and deterministic UQ methods focusing on spectral-normalized neural Gaussian process. Established upon the mathematical formulations, we subsequently examine the soundness of these UQ methods quantitatively and qualitatively (by a toy regression example) to examine their strengths and shortcomings from different dimensions. Then, we review quantitative metrics commonly used to assess the quality of predictive uncertainty in classification and regression problems. Afterward, we discuss the increasingly important role of UQ of ML models in solving challenging problems in engineering design and health prognostics. Two case studies with source codes available on GitHub are used to demonstrate these UQ methods and compare their performance in the life prediction of lithium-ion batteries at the early stage (case study 1) and the remaining useful life prediction of turbofan engines (case study 2).

Lifelong learning‐based multilayer neural network control of nonlinear continuous‐time strict‐feedback systems

AbstractIn this paper, we investigate lifelong learning (LL)‐based tracking control for partially uncertain strict feedback nonlinear systems with state constraints, employing a singular value decomposition (SVD) of the multilayer neural networks (MNNs) activation function based weight tuning scheme. The novel SVD‐based approach extends the MNN weight tuning to layers. A unique online LL method, based on tracking error, is integrated into the MNN weight update laws to counteract catastrophic forgetting. To adeptly address constraints for safety assurances, taking into account the effects caused by disturbances, we utilize a time‐varying barrier Lyapunov function (TBLF) that ensures a uniformly ultimately bounded closed‐loop system. The effectiveness of the proposed safe LL MNN approach is demonstrated through a leader‐follower formation scenario involving unknown kinematics and dynamics. Supporting simulation results of mobile robot formation control are provided, confirming the theoretical findings.

Идентификация: проблемы, тенденции, методические аспекты

For a commercial enterprise, the identification process as an element of the quality and safety assurance system is very important, as well as for consumers who come to a trading organization and choose the right and safe high quality product. Development of methodological aspects of its implementation is relevant. The methods of the process and system approaches used in the research process made it possible to build a logical chain, where identification, as a common denominator between quality and safety, is the dominant link in the process of selling goods at an enterprise, which is ensured by state regulation of system requirements and its components. A unified methodology for all trade enterprises has been developed on the basis of identifying requirements for the identification process and comparing it with the requirements for quality, safety and with the trade technological process. This methodology for the identification process was developed for the first time, which ensures the novelty and significance of the study. The approach to the formation of the methodology was based on the research of various scientists, who partially touched upon the problems of this development, the legal aspects of the problem in general and the reasons for the appearance of negative results of identification, which in turn causes scientific novelty, reflected in the improvement of the methodological approach to solving the problems of trade enterprises associated with ensuring the quality and safety of goods at the stages of acceptance and display. Ultimately, the developed methodology contributes not only to improving the quality of retail trade services at the regional level, but also allows local trade organizations to reach the level retailers from central regions of Russia, especially in the context of change management.

Safety Assurance Behaviour on Online Purchase among Orang Asli (Indigenous People) in Malaysia

Safety Assurance Behaviour on Online Purchase among Orang Asli (Indigenous People) in Malaysia

Food chain information for broilers: Results of a Europe-wide survey on status quo, usability and suggestions for improvement

A modern risk-based meat safety assurance system (RB-MSAS) for poultry includes information systems to better adapt to risks for food safety. Food Chain Information (FCI) according to Regulation (EC) No 853/2004 includes data on animal health, laboratory test results and further information that is relevant for consumer protection. FCI has to be transferred from the farm to the abattoir where the data analysis leads to adaptations of the slaughter process and/or meat inspection. As the EU regulation describes the required FCI imprecisely and without recommendations for meaningful reactions to specific information, implementation differs between European countries and even between abattoirs within one country. To assess the status quo of transfer, use and the usefulness of FCI in Europe, we conducted a survey on FCI for broilers among European stakeholders. The answers of 32 respondents, working in 14 different European countries as official veterinarians/meat inspection officers, food business operators/quality assurance managers, or in other positions in broiler meat hygiene, were included in the analysis. Overall, 75% (24/32) of the respondents stated they find FCI helpful for decision-making. All respondents (56%, 18/32) with electronic access to FCI find the transmission procedure practical. Most respondents get information about previous ante-mortem (81%, 26/32) and post-mortem (91%, 29/32) inspection results for flocks from the same holding of provenance. Likewise, most respondents receive data on mortality rate (88%, 28/32) and veterinary medications with a withdrawal period that have been administered during the fattening period (84%, 27/32). Overall, 53% of the respondents indicated that the entire fattening period would be the optimal relevant period for recording the administration of veterinary medications with a withdrawal period. In addition to this information, the respondents desired to have more data about further treatment (28%, 9/32) and data from the private veterinarian responsible for the farm (25%, 8/32). Knowledge of these data especially led to various measures being initiated at the abattoir, according to the respondents. In contrast, some specific production data were reported as also an important part of FCI, even though these data have little impact on the measures to protect human health that are taken in the slaughter process or at post-mortem inspection. All respondents transferred information about findings in the abattoir back to the farmers: these data were ante-mortem (72%, 23/32) and post-mortem (100%, 32/32) inspection results as well as further information (28%, 6/32). Our study shows that FCI for broilers is already widely successfully established as part of the RB-MSAS in Europe. Important information, like the ante- and post-mortem inspection results, is mostly available. Recommendations for improvement and for data to be included based on our study and literature are, inter alia: electronic data transfer; on-farm mortality; diseases occurring on-farm, especially those shortly before slaughter; all data on treatment with veterinary medications; EFSA's harmonised epidemiological indicators and; specific production data. Further studies are needed to gain a deeper understanding of correlations between ante-mortem data for the flock and findings at post-mortem inspection. Specific measures to be taken as a result of incoming information need to be stipulated in order that FCI is used more efficiently as a risk assessment tool in RB-MSAS.

Mesenchymal Stem Cell Therapy in Multiple Sclerosis: A Systematic Review and Meta-Analysis.

The assurance of safety and effectiveness is a significant focal point in all therapeutic approaches. Although mesenchymal stem cells (MSCs) have been identified as a potential novel therapeutic strategy for multiple sclerosis (MS), existing evidence regarding the effectiveness and safety of this strategy remains inconclusive. Thus, the primary aim of this systematic review and meta-analysis (SRMA) was to comprehensively assess the effectiveness and safety of MSC therapy in individuals diagnosed with MS. A comprehensive search was conducted using appropriate keywords in the PubMed, Scopus, Cochrane, ScienceDirect, and Google Scholar databases to determine the eligible studies. The change in the expanded disability status scale (EDSS) score from baseline to follow-up was used to assess MSC efficacy. The effectiveness of the therapy was assessed using a random-effects model, which calculated the combined prevalence and 95% confidence intervals (CIs) for MS patients who experienced improvement, stability, or worsening of their condition. The protocol was registered in PROSPERO (CRD42020209671). The findings indicate that 40.4% (95% CI: 30.6-50.2) of MS patients exhibited improvements following MSC therapy, 32.8% (95% CI: 25.5-40.1) remained stable, and 18.1% (95% CI: 12.0-24.2) experienced a worsening of their condition. Although no major complications were observed, headaches 57.6 [37.9-77.3] and fever 53.1 [20.7-85.4] were commonly reported as minor adverse events. All of the results reported in this meta-analysis are consistent and credible according to the sensitivity analyses. Regardless of different individual studies, our meta-analysis provides a comprehensive overview showing the potential of MSC therapy as a possible effective treatment strategy for patients with MS.

ЭКОЛОГИЧЕСКАЯ БЕЗОПАСНОСТЬ В РОССИЙСКОЙ АРКТИКЕ: НАДЛЕЖАЩИЕ ИНСТРУМЕНТЫ ПРАВОВОГО РЕГУЛИРОВАНИЯ

The article reveals the terminological content of the concept of «environmental safety». 
 It is argued that environmental safety in the Arctic can and should be ensured by a system that includes legal, economic, technological and other measures applied in the present and future times. Taking into account the declared features of the Arctic zone of the Russian Federation, special approaches to legal assurance of environmental safety are determined. The use of a software approach in the field of environmental protection and environmental management in the Arctic is being analyzed. It is proposed to adopt a special law «On environmental protection of the Arctic zone of the Russian Federation», taking into account the features of vulnerable arctic ecosystems.

Software Safety Assurance in Non-airborne GPS-based Landing Aids

This paper investigates the software standard DO-278A from the RTCA according to assurance level 3 to provide a concept for approving software of ground-based navigation aids. For this purpose, related literature and standards were reviewed and evaluated for their applicability for proposing such a concept. The resulting approval concept shows our approach for conducting the development process according to DO-278A based on a traditional one and focusing on an activity schedule. Therefore, the paper offers preliminary considerations at first to show the relation between system and software development. In addition, corresponding standards that are related to the development are presented as well. The concept is segmented in three main phases for software planning, realization, and verification, which are subdivided and scheduled in specific activities. Each activity consists of an outline describing the contents expected by DO-278A and our approach to organizing them. This paper shows our conceptional approach to obtain an approval for software according to DO-278A. This concept is prepared to approve a radio navigation aid.

Quality Assurance of Medicines: Main Scientific Approaches and Control Methods

The most important component of national health policy is the assurance of quality, efficacy, and safety of medicines entering the pharmaceutical market in the Russian Federation. In this interview, we have discussed the quality control of medicines; its interconnections with various branches of science, in particular, with analytical chemistry; and the matters of material and equipment supply with Elena L. Kovaleva (Doctor of Pharmaceutical Sciences, Deputy Director of the Centre for Medicinal Products Evaluation and Control of the Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation), Yuri A. Zolotov (Academician of the Russian Academy of Sciences, Full Professor, Doctor of Chemical Sciences), and Dmitry V. Somov (Candidate of Pharmaceutical Sciences, Acting Director General of the Information and Methodological Center for Expertise, Accounting, and Analysis of the Circulation of Medicinal Products of the Federal Service for Surveillance in Healthcare).