A5066773098- SARS-CoV-2 and COVID-19 Research
- Pharmacovigilance and Adverse Drug Reactions
- Computational Drug Discovery Methods
- Viral gastroenteritis research and epidemiology
- Urticaria and Related Conditions
- COVID-19 Clinical Research Studies
- Biosimilars and Bioanalytical Methods
- Pharmaceutical studies and practices
- Osteoarthritis Treatment and Mechanisms
- Pharmaceutical Quality and Counterfeiting
- Urinary Tract Infections Management
- Pharmacogenetics and Drug Metabolism
- Drug-Induced Hepatotoxicity and Protection
- Cancer therapeutics and mechanisms
- Collagen: Extraction and Characterization
- Knee injuries and reconstruction techniques
- Gout, Hyperuricemia, Uric Acid
- Animal Virus Infections Studies
- Statistical and Computational Modeling
- Migraine and Headache Studies
- Periodontal Regeneration and Treatments
- Biochemical and Molecular Research
- Biomedical and Engineering Education
- Electrolyte and hormonal disorders
- Statistical Methods in Clinical Trials
North-Western State Medical University named after I.I. Mechnikov
2021-2025
Sechenov University
2023
International Academy of Ecology, Human and Nature Safety
2020
While the world is experiencing another wave of COVID-19 pandemic, global vaccination program hampered by an evident shortage in supply licensed vaccines. In effort to satisfy vaccine demands we developed a new single-dose based on recombinant adenovirus type 26 (rAd26) vector carrying gene for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) glycoprotein - "Sputnik Light".We conducted open label, prospective, non-randomised phase 1/2 trial aimed assess safety,...
The authors developed a methodology for an in-depth study of the safety pharmacotherapy based on quantitative integrated analysis adverse events in context clinical trials. was tested using data obtained during bioequivalence trastuzumab. Objective. Practical implementation approaches by individualized assessment integral events. Materials and methods. This five-step algorithm modifies information regarding registered Subsequent drug events, which each event is assigned certain score...
Introduction. Current strategies for treating osteoarthritis (OA) are based on a multimodal approach that includes pharmacological and non-pharmacological methods. Undenatured chicken collagen type II (NK2) is considered safe effective maintaining joint health can be used alone combined with drugs OA treatment. Aim. To further evaluate the efficacy of combination Artneo containing NK2 in patients stage III knee compared placebo multicenter, prospective, double-blind, placebo-controlled,...
We have developed Convacell®—a COVID-19 vaccine based on the recombinant nucleocapsid (N) protein of SARS-CoV-2. This paper details Convacell’s® combined phase I/II and IIb randomized, double-blind, interventional clinical trials. The primary endpoints were frequency adverse effects (AEs) titers specific anti-N IgGs induced by vaccination; secondary included nature immune response. Convacell® demonstrated high safety in I with no severe AEs detected, 100% seroconversion day 42 sustained for...
Non-pharmacological treatments based on collagen as a dietary supplement are emerging new area of interest to support preventive or therapeutic effects in patients with osteoarthritis (OA).
Comparative evaluation of the pharmacokinetics, safety profile and tolerability Ranquilon® 1 mg tablets with a single administration under fasting fed conditions among healthy male female volunteers.
The aim. Study of pharmacodynamic parameters and confirmation equivalence (bioequivalence) the drugs Antareit® (INN: magaldrate), chewable tablets, 800 mg (Valenta Pharm JSC, Russia) Riopan (INN (Takeda GmbH, Germany). Material methods. An open randomized crossover study was conducted to investigate pharmacodynamics drug reference Riopan, assessing their bioequivalence after taking 2 tablets or 3 times a day. involved 40 healthy volunteers who were into groups 20 people depending on sequence...
Background: While the world is experiencing another wave of COVID-19 pandemic, global vaccination program hampered by obvious shortage in supply licensed vaccines. Development new vaccines that are easy to manufacture and administer highly desirable overcome hurdles vaccine scaling up distribution, especially developing countries. In effort satisfy demands we developed a single dose based on recombinant adenovirus type 26 (rAd26) vector carrying gene for severe acute respiratory syndrome...
Relevance. Planning the design of bioequivalence clinical studies generic highly variable drugs requires non-standard approaches – use replicative (repeated) or adaptive design. However, both entail an increase in organizational, time, and financial costs. Therefore, it becomes relevant to search for ways pre-select volunteers with a lower initial level variability pharmacokinetic parameters reduce number subjects. Objective. The aim this study was determine potential subjects trials low...
Aim . To study the comparative pharmacokinetics and confirmation of bioequivalence generic (T) original (R) dabigatran etexilate in healthy volunteers after a single oral dose under fasted conditions. Material methods confirm bioequivalence, an open-label, randomized, replication, crossover, four-step was conducted to compare with 150 mg conditions adult male female volunteers. Sixty-eight subjects participated study. During study, blood plasma samples were taken from volunteers, which...
SCIENTIFIC RELEVANCE. The safety assessment of investigational medicinal products is a mandatory step in clinical trials all phases, including bioequivalence studies. However, there are no approaches providing for the individualised adverse drug reactions (ADRs), which contributes to quality decisions on pharmacotherapy. AIM. study aimed develop and justify pharmacotherapy based quantitative integrative analysis events (AEs). MATERIALS AND METHODS. authors carried out systematic review...
Molnupiravir is one of the drugs for etiotropic therapy a new coronavirus infection COVID-19. It has confirmed its clinical efficacy in treatment patients with mild and moderate COVID-19, including those who are at high risk progressing to severe disease. The aim study was evaluate bioequivalence generic drug molnupiravir ALARIO-TL original Lagevrio single oral administration healthy volunteers. Materials methods. This an open, randomized, two-period crossover study. In each two periods,...
Gout is one of the most common forms inflammatory arthritis. Medical care for gout includes non-steroidal anti-inflammatory drugs (NSAIDs). This paper reviews efficacy and safety NSAIDs prescribed acute attack gout, in particular, AMBENIUM® parenteral. It was demonstrated that phenylbutazone a powerful NSAID provides significant analgesic effects. Considering broad spectrum adverse reactions NSAIDs, these agents should be used under in-depth analysis patient’s condition, comorbidities level...
Fludarabine is a purine antimetabolite with pronounced immunosuppressive effect. The inhibitory effect of fludarabine depends on its concentration in blood plasma. In addition, the phenotypic characteristics patients affect pharmacokinetic and pharmacodynamic profile drug, which necessitates personalized approach to dosage regimen. chromatography-mass spectrometric method for quantitative determination 2-fluorine plasma was developed studying individual parameters pharmacokinetics...
Non-steroidal anti-inflammatory drugs are widely used by patients and medical workers, both in the Russian Federation abroad. Despite well-established public opinion about safety of this group drugs, their use is associated with toxic reactions. This study analyzed download national database “Pharmacovigilance” for 11 years (for period 2010 to 2020) identification main representatives class that cause adverse To compare several independent samples who received different groups NSAIDs,...
BACKGROUND: Ebastine is widely used in medical practice for treating urticaria and allergic rhinitis. This compound an antiallergic drug that belongs to the second generation of H1 histamine receptor blockers. The effectiveness ebastine can be observed when it orally administered. As a part registration trade name Allergostin, clinical study its bioequivalence with Kestin was conducted involving 26 healthy volunteers.
 AIM: To summarize results comparative pharmacokinetics...
The aim. primary objective of the study was to evaluate effect food on bioavailability Aterixen ® 100 mg tablet after single oral dose under fasting or fed conditions. secondary pharmacokinetic parameters, safety, and tolerability Materials methods. Healthy male female volunteers aged 18 45 years were included in study. Due lack data about intra-individual variability main parameters active substance (XC221GI, 1-[2-(1-Methylimidazol-4-yl)-ethyl]perhydroazin-2,6-dione), an adaptive group...
In order to evaluate the bioequivalence and benefits of a new dosage form type 5 phosphodiesterase inhibitor, sildenafil, two open-label studies in healthy male volunteers were carried out.An open, randomized, crossover study compare pharmacokinetics after single dose sildenafil at 50 mg on an empty stomach spray (test drug) traditional tablet (comparison 44 (18 43 years old) was done. To assess effect food intake pharmacokinetics, non-randomized conducted 6 (from 23 35 who received (50 mg)...
Relevance. Interpretation of the preclinical trials data is fundamental importance. The correctness extrapolation obtained from animals to humans due qualitative and quantitative diversity systems tested recorded parameters approaches their interpretation, as well statistical methods in determining possible risk humans. Aim. Comparative assessment safety tolerability during clinical Reamberin® (LLC «POLYSAN») development improving trial planning processes for assessing tolerability, taking...