ABSTRACT
Nirmatrelvir is an antiviral drug that, in combination with ritonavir, is an effective agent for the etiotropic therapy of patients with mild to moderate COVID-19. The aim of the study was to evaluate bioequivalence of the generic drug nirmatrelvir Arpaxel in combination with ritonavir and the original drug Paxlovid, which is a combination of nirmatrelvir/ritonavir, in a single dose administration to healthy volunteers.Materials and methods. This research was an open-label, randomized, two-period crossover bioequivalence study. It included 2 periods, in each of which the volunteers received either a test drug (nirmatrelvir at the dose of 300 mg) in combination with ritonavir (100 mg), or a reference drug (a combination of nirmatrelvir 300 mg and ritonavir 100 mg), given as a single dose. A wash-out period between each of the administrations was 7 days. The blood sampling to determine the concentration of nirmatrelvir was carried out in the range from 0 to 36 h in each of the study periods. A nirmatrelvir concentration was determined by a validated HPLC-MS/MS method with a lower quantitation limit of 10 ng/mL. Bioequivalence was assessed by comparing 90% confidence intervals (CIs) for the ratio of geometric means of AUC(0-36) and Cmax of the test drug and reference drugs with the established equivalence limits of 80.00-125.00%.Results. In the study were included 68 healthy volunteers, 67 participants of which were included in the bioequivalence population. The pharmacokinetic parameters of the drugs were comparable to each other. The 90% confidence interval for the ratio of the geometric mean of the maximum drug concentration in the blood plasma and the area under the pharmacokinetic curve << concentration-time >> from zero to the last blood draw within 36 hours of nirmatrelvir was 87.26-100.83 and 93.27-103.74%, which meets the criteria for assessing bioequivalence. The test drugs were well tolerated by the volunteers. The incidence of adverse events was similar for the test and reference drugs. No serious adverse events were recorded during the entire study.Conclusion. As a result of this study, bioequivalence of the test and reference drugs has been established.
ABSTRACT
Today, large amounts of data are being continuously produced, collected, and exchanged between systems. As the number of devices, systems and data produced grows up, the risk of security breaches increases. This is all the more relevant in times of Covid-19, which has affected not only the health and lives of human beings' but also the lifestyle of society, i.e. the digital environment has replaced the physical. This has led to an increase in cyber security threats of various nature. While security breaches and different security protection mechanisms have been widely covered in the literature, the concept of a "primitive” artifact such as data management system seems to have been more neglected by researchers and practitioners. But are data management systems always protected by default? Previous research and regular updates on data leakages suggest that the number and nature of these vulnerabilities are high. It also refers to little or no DBMS protection, especially in case of NoSQL, which are thus vulnerable to attacks. The aim of this paper is to examine whether "traditional” vulnerability registries provide a sufficiently comprehensive view of DBMS security, or they should be intensively and dynamically inspected by DBMS owners by referring to Internet of Things Search Engines moving towards a sustainable and resilient digitized environment. The paper brings attention to this problem and makes the reader think about data security before looking for and introducing more advanced security and protection mechanisms, which, in the absence of the above, may bring no value. © 2023, The Author(s), under exclusive license to Springer Nature Switzerland AG.
ABSTRACT
Molnupiravir is one of the drugs for the etiotropic therapy of a new coronavirus infection COVID-19. It has confirmed its clinical efficacy in the treatment of patients with mild and moderate COVID-19, including those who are at high risk of progressing to severe disease. The aim of the study was to evaluate bioequivalence of the generic drug molnupiravir ALARIO-TL and the original drug Lagevrio with a single oral administration in healthy volunteers. Materials and methods. This bioequivalence study was an open, randomized, two-period crossover study. In each of the two periods, volunteers received a single dose of the test drug, or reference drug molnupiravir, in the form of capsules at the dose of 200 mg. The washout period between the doses was 3 days. To determine pharmacokinetic (PK) parameters and bioequivalence, the concentration the concentration of N-hydrozycytidine (NHC), the main molnupiravir metabolit in the blood plasma of volunteers was evaluated. The blood plasma sampling was carried out in the range from 0 to 16 hours in each of the study periods. Bioequivalence was assessed by comparing 90% confidence intervals (CIs) for the ratio of geometric means of AUC(0-16) and Cmax of the test drug and reference drugs with the established equivalence limits of 80.00 - 125.00%. Results. A total of 28 healthy male volunteers were included in the study. According to the results of the statistical analysis, after the administration of the test and reference drugs, the 90% CIs for the ratio of the geometric means of AUC (0-16) and Cmax were 96.31% - 113.64% and 91.37% - 114.8%, respectively. These intervals fit within the established limits of 80.00-125.00%, which confirms the bioequivalence of the drugs. When comparing the frequency of the individual adverse events registration, no significant differences were found out after the administration of the test and reference drugs. Conclusion. Based on the results of this study, it can be concluded that the test and reference drugs of molnupiravir are bioequivalent. In addition, the data obtained indicate that the drugs have similar safety profiles.Copyright © 2022 Volgograd State Medical University, Pyatigorsk Medical and Pharmaceutical Institute. All rights reserved.
ABSTRACT
Today, more and more people are reporting allergies, which can range from simple reactions / discomfort to anaphylactic shocks. Other people may not be allergic but avoid certain foods for personal reasons. Daily food shopping of these people is hampered by the fact that unwanted ingredients can be hidden in any food, and it is difficult to find them all. The paper presents a digital health shopping assistant called 'Diet Helper', aimed to make life easier for such people by making it easy to determine whether a product is suitable for consumption, according to the specific dietary requirements of both types - existing diet and self-defined. This is achieved by capturing ingredient label, received by the app as an input, which the app analyses, converting the captured label to text, and filters out unwanted ingredients that according to the user should be avoided as either allergens or products to which the consumer is intolerant, helping the user decide if the product is suitable for consumption. This should make daily grocery shopping easier by providing the user with more accurate and simplified product selection in seconds, reducing the total time spent in the grocery stores, which is especially relevant in light of COVID-19, although it was and will remain out of it due to the busy schedules and active rhythm of life of modern society. The app is developed using the React Native framework and Google Firebase platform, which makes it easy to develop, use and extend such solutions thereby encouraging to start actively developing solutions that could improve wellbeing. © 2022 IEEE.
ABSTRACT
Today, the topic of child’s sporting has become a crucial, not only because, in the 21st century, computer games and social networks are the most common way of spending a child leisure time (shift from sports to eSports took place), but also because in 2020, Covid-19 and the associated restrictions give parents even more stress on visits to sports clubs. In addition, sports may lead to unpleasant situations when a child is not successful enough in the particular discipline and is publicly criticized, thereby undermining his willingness to sport. We suppose that the trends of digitalization and some aspects of Industry 4.0, would be able to solve these issues at least partly, without requiring a lot of resources from child’s sports clubs. This paper is devoted to a simple technological solution that would improve the sports club business by facilitating the exchange of information between a child, parents and sports clubs. © 2021, Springer Nature Switzerland AG.