A5023787037- Biomedical Ethics and Regulation
- Biosimilars and Bioanalytical Methods
- SARS-CoV-2 and COVID-19 Research
- Viral Infectious Diseases and Gene Expression in Insects
- Viral gastroenteritis research and epidemiology
- CAR-T cell therapy research
- Biotechnology and Related Fields
- Virus-based gene therapy research
- Biomedical and Engineering Education
- Protein purification and stability
- Analytical Chemistry and Chromatography
- NMR spectroscopy and applications
- Influenza Virus Research Studies
- Computational Drug Discovery Methods
- Pharmaceutical Economics and Policy
- CRISPR and Genetic Engineering
- Monoclonal and Polyclonal Antibodies Research
- Bacteriophages and microbial interactions
- COVID-19 Clinical Research Studies
- Geophysics and Sensor Technology
- Science, Research, and Medicine
- Seismic Waves and Analysis
- Advanced Neuroimaging Techniques and Applications
- Advanced MRI Techniques and Applications
- Viral Infections and Vectors
Sechenov University
2018-2024
Ministry of Health of the Russian Federation
2014-2024
Federal Medical-Biological Agency
2023
IFC Research (United Kingdom)
2021-2023
Institute of Professional Evaluation
2018-2022
Norwegian Center of Expertise
2020
Federal State Budgetary Institution "Center for Expertise and Quality Control of Medical Care"
2012-2018
Ministry of Health
2003
Severe acute respiratory syndrome corona virus (SARS-CoV-2) infection frequently causes severe and prolonged disease but only few specific treatments are available. We aimed to investigate safety efficacy of a SARS-CoV-2-specific siRNA-peptide dendrimer formulation MIR 19® (siR-7-EM/KK-46) targeting conserved sequence in known SARS-CoV-2 variants for treatment COVID-19.We conducted an open-label, randomized, controlled multicenter phase II trial (NCT05184127) evaluating inhaled...
SCIENTIFIC RELEVANCE. The use of appropriately certified reference standards (RSs) is a necessary element analytical procedure standardisation that ensures comparability results across different laboratories assessing the quality medicines, which important for control biologicals. Marketing authorisation involves providing information on RSs, but no specific requirements are given relevant section dossier. Therefore, it to develop appropriate guidelines. AIM. This study aimed materials...
Coronaviruses are the largest group of known positive-strand RNA viruses. Coronavirus infection can affect various animal species, as well humans. Over past two decades, coronaviruses have caused epidemic outbreaks respiratory diseases: Middle East Respiratory Syndrome and Severe Acute Syndrome. At end 2019, a new type virus was detected in China. The has been spread by humantohuman transmission viral pneumonia outbreak. emergence coronavirus proves that diseases this viruses pose threat to...
INTRODUCTION. Chickenpox is a highly contagious viral disease that primarily affects preschool children. A number of chickenpox vaccines are licensed worldwide, but there still gaps in vaccination coverage. may differ efficacy, and certain issues with their long-term effectiveness remain unresolved. have different safety profiles, lingering concerns about adverse effects. These considerations highlight the need for further monitoring development programmes. AIM. This study aimed to summarise...
INTRODUCTION. A well-planned design of a clinical trial (CT) ensures valid results in assessing the efficacy and safety medicines for human use. However, at present, there are no clear criteria selecting basic elements underlying development CT design. This lack selection primarily concerns planning research hypotheses, calculating expected therapeutic effect, statistical significance level, study power, models sample size calculation. AIM. The authors aimed to systematise harmonise...
The review analyses measles incidence in Russia at the elimination stage. Epidemiological studies have revealed changes epidemic process Russia. It was shown that whereas specificity of pre-vaccination period mainly determined by influence infectious agent, lately impact social factor has increased. There an increase decreed groups on maintaining circulation virus Russian Federation. aim study to analyse Russia, identify major current problems vaccination, reveal reasons prevent country...
Neurodegenerative diseases (NDDs) are promising objects for the development of gene therapy products, primarily, due to possible cause these (disruption a or several genes), lack effective therapy, and negative impact on quality life both patients their families friends. The aim study was identify trends challenges in preclinical clinical studies products NDDs analyse international experience expert assessment dossier Zolgensma®, which received conditional marketing authorisation. According...
Chikungunya fever is an acute infectious disease caused by the mosquito-borne virus (CHIKV). In last decades, cases of have been reported in more than 100 countries; therefore, CHIKV presents a global public health problem. genotypes limited antigenic diversity, and documented reinfection very rare. Hence, vaccine could prevent infection potential disability, as well reduce epidemic spread population. The aim study was to review approaches development preventive vaccines against CHIKV,...
This review focuses on DNA and RNA vaccines whose potential use was first considered at the end of 20th century. However, not a single bacterial plasmid-based or mRNA vaccine has been used since that time in public healthcare for prevention infectious diseases. Nevertheless, containing recombinant nucleic acids as active ingredient still attract interest due to possibility rapid development, low-cost production, safety technology activate cellular humoral immunity. Recent technological...
Nanoscale drugs differ in special physicochemical, biological, pharmacokinetic parameters. These properties can be used to provide targeted delivery, prolong the action of drugs, as well reduce their side effects. An important problem that needs attention is study potential risks arising from treatment such drugs. The aim : analysis requirements domestic and foreign regulators for safety nanoscale paper presents classification most promising nanosystems containing an existing principles...
There are a lot of diseases known today, which caused by genetic abnormalities. Advances in genetics and biotechnology brought about gene editing technologies that can produce almost any gene, ultimately led to the emergence new class medicines - therapy products (GTPs). The aim study was analyse international experience development authorisation GTPs. review highlights challenges GTP development, related search for an optimal approach therapeutic delivery target cells. Viral vectors were...
Advances in ex vivo technologies of human genome editing have made it possible to develop new approaches the treatment genetic, oncological, infectious and other diseases, which may involve use biomedical cell products. However, despite rapid development these a large number clinical trials conducted many countries around world, only 4 products (Strimvelis, Zalmoxis, Kymriah Yescarta) containing genetically modified cells are authorised for European Union United States America. This paper...