Introduction. The increase in incidence rate of pertussis worldwide, short-term insufficient immunity induced by acellular vaccines (TDaP) and their failure to provide antibacterial protection prevent transmission infection human population dictate the development new vaccines. A live recombinant vaccine for intranasal use (GamLPV) has completed preclinical studies experiments on nonhuman primates 2 phases clinical trials involving adult healthy volunteers, which safety, immunogenicity...

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...

The article presents the results of a study working conditions and morbidity public civil servants in St. Petersburg based on statistical processing mandatory medical examinations 2017, 2019 2023 for total 19797 people. It is determined that servants, regardless sectoral sphere executive authority, are characterized by an increased level risk factors stressful situations affect occurrence diseases lead to deterioration health. structure main included: eye its accessory apparatus (21.51 %),...

The article reviews scientific literature and analyzes regulatory methodological documents on health protection (including mental health) of workers in various industries order to determine the probability occupational stress development nuclear shipbuilding ship repair enterprises possible ways reduce its impact professional activity. It has been established that working conditions characteristic for different can cause negatively influencing their health, labor longevity productivity. is...

The implementation of a complex risk-oriented approach at all stages drug development, including the preclinical research stage, is essential for ensuring safety, quality and effi cacy. aim study was to justify benefits introducing risk management into integrated system trial stage. optimal implementing stage an overall process based on international standard ISO 31000:2009 Risk management—Principles guidelines. This as applied centre includes three-tier level operational subsystems, testing...

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...

Introduction. The issues of sanitary and epidemiological welfare in workers when performing diving operations require close attention from the state, are part structure Concept development Russia, relevant to society. To date, there several problems not only hygienic rationing, but also medical provision operations. purpose study is working conditions subjective assessment health status employees operations, develop proposals for improving legislation. Materials methods. analysis normative...

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...

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...

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...

Chromosomal aberrations analysis was performed in peripheral blood lymphocytes of the two groups Siberian Chemical plant employers – sublimation factory staff and administration. frequency (7,24±0,048 per 100 cells) were significantly (р0,001) increased relative to administration group (1,29±0,66 mainly because increasing single fragments. This type chromosomal 6,4±0,41 cells vs. 1±0,52 (p0,001). The rates chromatid chromosome types comprised. high level indicate mutagenicity occupational...

The aim. aim of the study is to determine prognostically significant criteria for reversibility suppression generation bioelectrical activity using an experimental model alcoholic coma. Materials and methods. work was performed on 27 nonlinear sexually mature rats weighing 340±40 g, which received a 40% solution ethyl alcohol by oral route in fractional doses 12.6 g/kg, corresponded LD50. EEG monitoring until there definite effect (from 1 54 hours). Results. In favorable outcome coma (11...

Проведен сравнительный анализ фармакокинетических параметров янтарной кислоты после внутривенного введения препаратов «Унифузол, раствор для инфузий 1,4 %», «Реамберин, 1,5 «Ремаксол инфузий», «Цитофлавин, введения» (ООО «НТФФ «ПОЛИСАН», г. Санкт-Петербург) по результатам серии клинических исследований, осуществленных в 2017 – 2022 гг. Установлено, что двухкамерная модель является оптимальной определения фармакокинетики кислоты, получены значимые различия между исследуемыми препаратами...

To simulate a convulsive syndrome, phenylcarbamate was administered intraperitoneally at dose of 1 mg/kg. Valproic acid aminoester (43 mg/kg), caramiphene (50 and diferidine (2 mg/kg) were investigated as potential anticonvulsant drugs. Blood brain tissue for the determination acetylcholinesterase (AСhE) taken 10, 30, 60 minutes, 6 24 hours after administration xenobiotic. In case poisoning with reversible inhibitors AChE accumulation acetylcholine in CNS synapses (due to inhibition...

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...

The article presents the results of evaluation actoprotective activity combined dimethylaminoethanol compounds containing intermediates citric acid cycle (L-malate, α-ketoglutarate, succinate and fumarate). effect long-term intragastric administration pharmacological agents for 4 weeks at a dose 75 mg/kg on static, dynamic endurance, motor coordination body weight gain “trained” laboratory animals was assessed in comparison with reference actoprotector ethylthiobenzimidazole (25 mg/kg,...

This article presents the results of assessing effect course administration dimethylaminoethanol derivatives in various modes on static and dynamic endurance small laboratory animals during training loads. It was found that ketoglutarate has greatest physical animals, while malate — endurance.