Персона: Савченко, Алла Юрьевна
Загружается...
Email Address
Birth Date
Научные группы
Организационные подразделения
Организационная единица
Инженерно-физический институт биомедицины
Цель ИФИБ и стратегия развития – это подготовка высококвалифицированных кадров на базе передовых исследований и разработок новых перспективных методов и материалов в области инженерно-физической биомедицины. Занятие лидерских позиций в биомедицинских технологиях XXI века и внедрение их в образовательный процесс, что отвечает решению практикоориентированной задачи мирового уровня – диагностике и терапии на клеточном уровне социально-значимых заболеваний человека.
Статус
Фамилия
Савченко
Имя
Алла Юрьевна
Имя
6 results
Результаты поиска
Теперь показываю 1 - 6 из 6
- ПубликацияТолько метаданныеApplication of in vitro studies to predict the pharmacokinetics of rivaroxaban tablets(2024) Suvorova, A. V.; Losenkova, P. A.; Medvedev, Yu. V.; Malashenko, E. A.; Savchenko, A. Y.; Савченко, Алла Юрьевна"Introduction. The most important stage of pharmaceutical development of a generic drug is a clinical trial involving humans ў?? a bioequivalence study. Considering the importance of finding rivaroxaban drugs in the list of vital and essential drugs, as part of ensuring technological sovereignty, the use of scientific robust and effective methods for determining the quality of the dosage form is required. Aim. Conduct a study of rivaroxaban tablets on a physiologically relevant tester to predict pharmacokinetic profiles. Materials and methods. The objects of the study are ""Xarelto‚?, film-coated tablets, 10 mg"" (series BXJS871, with an expiration date of October 31, 2024, Bayer AG, Germany), ""Xarelto‚?, film-coated tablets, 20 mg"" (series BXKDF32, with an expiration date of May 17, 2026, Bayer AG, Germany) and ""Rivaroxaban, film-coated tablets, 10 mg"" and ""Rivaroxaban, film-coated tablets, 20 mg"", domestically produced, with valid expiration dates. During the study, reagents were used to prepare dissolution media and perform quantitative determination. The physiologically relevant test was performed on the SC PRT-6 device (LLC ""Scientific Compliance"", Russia). The quantitative content of released rivaroxaban within the comparative dissolution kinetics test in a medium of 0.1 in a medium of 0.1 % sodium lauryl sulfate solution in a phosphate buffer solution pH 6.5 was carried out on a SF-2000 spectrophotometer (LLC ""OKB Spektr"", Russia). The quantitative content of released rivaroxaban within the comparative dissolution kinetics test in biorelevant dissolution media and physiological relevance test was assessed on a high-performance liquid chromatograph ""Chromatec-Crystal HPLC 2014"" (CJSC ""Chromatec"", Russia). Pharmacokinetic profiles were modeled in the PK-Sim‚? (Systems Biology Software Suite 11.2, Bayer Technology Services GmbH, Germany) program based on the data obtained within the physiologically relevant test. The clinical study of rivaroxaban tablets was a prospective, open-label, randomized, crossover, two-stage comparative study in two groups of volunteers with a single dose of drugs on the fast condition. The study randomized 30 healthy male volunteers aged 18ў??45 years. Results and discussion. A complex of in vitro tests was conducted, profiles were obtained that allow us to evaluate the dynamics and degree of release of the studied drugs in various parts of the human gastrointestinal tract. A comparison of the sequential and hybrid schemes for conducting the physiological relevance test was carried out. Within the framework of the set of tests, qualitative and quantitative correlation with the clinical trials data was observed only for the hybrid physiological relevance test scheme. Based on the results of physiological relevance test using different schemes, pharmacokinetic profiles for a pair of drugs were predicted and the prediction error was assessed. Conclusion. A set of scientific in vitro tests was conducted for the drugs ""Xarelto‚?, film-coated tablets, 10 mg and 20 mg"", ""Rivaroxaban, film-coated tablets, 10 mg and 20 mg"". Based on the physiological relevance test results, pharmacokinetic profiles for a pair of drugs were predicted with low error and high reliability. As part of the comparison of data obtained during clinical trial and modeling, the smallest prediction error was noted when performing physiological relevance test using a hybrid scheme."
- ПубликацияТолько метаданныеDevelopment and validation of tranexamic acid determination in human plasma by hplc-ms/ms method(2021) Aleshina, A. V.; Archakova, O. A.; Shchelgacheva, D. S.; Bagaeva, N. S.; Komarov, T. N.; Savchenko, A. Yu.; Савченко, Алла Юрьевна© Aleshina A. V., Komarov T. N., Archakova O. A., Shchelgacheva D. S., Bagaeva N. S., Davydanova V. V., Savchenko A. Yu., Shohin I. E., 2021.Introduction. Tranexamic acid is one of the most common drugs used to stop bleeding after trauma, in surgery and gynecology. The most common analytical method for the determination of this compound is reversed-phase high-performance liquid chromatography (HPLC). However, this compound belongs to the group of so-called poorly retained compounds due to its chemical structure. It is necessary to develop an analytical method that will allow the determination of tranexamic acid in human blood plasma with the least time, resource costs and without the use of specialized columns. Aim. The aim of this study is to develop a method for tranexamic acid in human plasma by high performance liquid chromatography with tandem mass-spectrometry (HPLC-MS/MS) for pharmacokinetic studies. Materials and methods. Determination of tranexamic acid in plasma by HPLC-MS/MS. The samples were processed by acetonitrile protein precipitation. Results and discussion. This method was validated by next parameters: selectivity, matrix effect, calibration curve, accuracy, precision, recovery, lower limit of quantification, carry-over effect and stability. Conclusion. The method of the determination of tranexamic acid in human plasma was developed and validated by HPLC-MS/MS. The linearity in plasma sample was achieved in the concentration range of 100.00–15000.00 ng/ml. Method could be applied to tranexamic acid determination in plasma for pharmacokinetics and bioequivalence studies.
- ПубликацияТолько метаданныеHygienic Monitoring of Working Area Air Pollution by Particulate Matter of ticagrelator in the Pharmaceutical Factory(2022) Pozharnov, I. A.; Simakov, A. S.; Shulga, N. A.; Savchenko, A. Yu.; Perederyaev, O. I.; Synkova, L. S.; Medvedev, Y. V.; Fisher, E. N.; Савченко, Алла ЮрьевнаIntroduction. Hygienic monitoring of air pollution at the pharmaceutical enterprise required by the law of the Russian Federation (orders, standards, methodological guidelines and guidelines). This requirement follows from the need to protect the personnel of the pharmaceutical plant from the adverse air conditions of the working area, which may contain suspended solids of active pharmaceutical ingredient (API). Despite the use of breathing equipment by staff and occupational safety requirements, the risk to workers should be minimized by regular assessment of air pollution. Aim. The purpose of the stady is to carry out hygienic monitoring of working area air tikagrelor – API of the medicinal preparation Brilinta®. Materials and methods. The subject of this research is API ticagrelor including air and flush samples from the surface of LLC «AstraZenica Industries», collected during the production of the consignment of Brilinta® (MNN – ticagrelor). Air samples of the working area were collected using air intake systems of type "IOM Sampler", using both personal and stationary systems. Flushing from the surface is done by template v printing using cotton swaps. Sampling points selected to cover. All stages of the production cycle. Subsequently, the quantification of ticagrelor in samples was carried out by the method of high-efficiency liquid chromatography with UV detection (HPLC-UV). Results and discussions. The quantitative determination showed that 4 air samples and 25 surface fluxes exceeding the allowable content of ticagrelor. Each sample was related to the time and place of sampling, and assumptions were made as to why the sample points exceeded the standard values. Conclusion. At the pharmaceutical enterprise we have carried out hygienic monitoring of the working area air for the content of API ticagrelor. The results of the measurements were obtained and processed, on the basis of which measures were proposed to reduce the concentration of ticagrelor in the air in order to protect personnel from the adverse effects of the work area. These measures include optimization of process operations and/or training of personnel in new approaches to the operation and cleaning of equipment. © 2022, Center of Pharmaceutical Analytics. All rights reserved.
- ПубликацияТолько метаданныеDevelopment and Validation of the ELISA Method for Anti-trastuzumab Antibodies Determination in Human Serum(2022) Eliseeva, O. A.; Kolganova, M. A.; Shokhin, I. E.; Dementyev, S. P.; Dubovik, N. S.; Savchenko, A. Y.; Дубовик, Наталья Сергеевна; Савченко, Алла ЮрьевнаIntroduction. One of the widely used specific anti-HER 2 (human epidermal growth factor receptor 2) MAb drugs is trastuzumab. Trastuzumab is highly effective for malignant HER 2 hyperexpression reduction, which results in HER 2 oncogenicity decrease. As any other biotherapeutics trastuzumab can cause immunological adverse reactions, e.g. immunogenicity or anti-drug antibodies (ADAs) production. Aim. The aim of this study was to develop and validate the analytical method for anti-trastuzumab antibodies determination in human blood serum. Materials and methods. The semi-quantitative anti-trastuzumab antibody determination was carried out by the ELISA method combined with ACE technique, using spectrophotometric detection in the visible range of the spectrum. Results and discussion. The developed method was validated for cut point, selectivity, sensitivity, hook effect, drug tolerance, precision and stability (short-term and long-term). To decrease the background noise from non-specific binding of sera components, the minimum required dilution value was determined at 10 % serum. The calculated values for screening cut point (normalization factor) and confirmatory cut point were 0.004 and 34.59 %, respectively. The sensitivity of the developed method was estimated at 99.5 ng/mL of anti-trastuzumab antibodies. Conclusion. The obtained results allow us to use the developed ACE ELISA method for the determination of anti-trastuzumab antibodies in human serum during trastuzumab safety clinical trials.
- ПубликацияОткрытый доступDevelopment and validation of esomeprazole magnesium trihydrate determination in workplace air using HPLC-MS/MS(2025) Savchenko, A. Yu.; Zhiltcov, P. A.; Kartamyshev, I. I.; Guranda, D. T.; Савченко, Алла Юрьевна
- ПубликацияОткрытый доступPotential targets for the new anti-tuberculosis drug of the diarylquinoline group thiozonide(2025) Savchenko, A. Y.; Shilov, B. V.; Савченко, Алла Юрьевна