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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">pmedpharm</journal-id><journal-title-group><journal-title xml:lang="ru">Фармация и фармакология</journal-title><trans-title-group xml:lang="en"><trans-title>Pharmacy &amp; Pharmacology</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2307-9266</issn><issn pub-type="epub">2413-2241</issn><publisher><publisher-name>Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical Univer</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.19163/2307-9266-2025-13-4-246-259</article-id><article-id custom-type="elpub" pub-id-type="custom">pmedpharm-1710</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОРИГИНАЛЬНАЯ СТАТЬЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>RESEARCH ARTICLE</subject></subj-group></article-categories><title-group><article-title>PreKinetix: веб-приложение для проведения фармакокинетического анализа в доклинических исследованиях лекарственных препаратов</article-title><trans-title-group xml:lang="en"><trans-title>PreKinetix: web application for pharmacokinetic analysis in preclinical drug research</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0006-8806-6902</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Резванов</surname><given-names>П. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Rezvanov</surname><given-names>P. M</given-names></name></name-alternatives><bio xml:lang="ru"><p>аспирант, младший научный сотрудник лаборатории биоинформатики и фармакологического моделирования Центра биофармацевтического анализа и метаболомных исследований, Институт трансляционной медицины и биотехнологии, ФГАОУ ВО Первый МГМУ им. И.М. Сеченова Минздрава России (Сеченовский университет).</p><p>Россия, 119991, г. Москва, ул. Трубецкая, д. 8, стр. 2.</p></bio><bio xml:lang="en"><p>graduate student, junior researcher at the Laboratory of Bioinformatics and Pharmacological Modeling of the Center for Biopharmaceutical Analysis and Metabolic Research at the Institute of Translational Medicine and Biotechnology, I.M. Sechenov First Moscow State Medical University (Sechenov University). </p><p>2 Trubetskaya Str., Bldg 8, Moscow, Russia, 119991.</p></bio><email xlink:type="simple">rezvanov_p_m@staff.sechenov.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-7309-8913</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Москалева</surname><given-names>Н. Е.</given-names></name><name name-style="western" xml:lang="en"><surname>Moskaleva</surname><given-names>N. E.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат биологических наук, заместитель руководителя Центра биофармацевтического анализа и метаболомных исследований, Институт трансляционной медицины и биотехнологии, ФГАОУ ВО Первый МГМУ им. И.М. Сеченова Минздрава России (Сеченовский университет). </p><p>Россия, 119991, г. Москва, ул. Трубецкая, д. 8, стр. 2.</p></bio><bio xml:lang="en"><p>Candidate of Sciences (Biology), Deputy Head of the Center for Biopharmaceutical Analysis and Metabolic Research at the Institute of Translational Medicine and Biotechnology, I.M. Sechenov First Moscow State Medical University (Sechenov University). </p><p>2 Trubetskaya Str., Bldg 8, Moscow, Russia, 119991.</p></bio><email xlink:type="simple">moskaleva_n_e@staff.sechenov.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-6554-3936</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шестакова</surname><given-names>К. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Shestakova</surname><given-names>K. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат фармацевтических наук, заведующая лабораторией биоинформатики и фармакологического моделирования Центра биофармацевтического анализа и метаболомных исследований, Институт трансляционной медицины и биотехнологии, ФГАОУ ВО Первый МГМУ им. И.М. Сеченова Минздрава России (Сеченовский университет). </p><p>Россия, 119991, г. Москва, ул. Трубецкая, д. 8, стр. 2.</p></bio><bio xml:lang="en"><p>Candidate of Sciences (Pharmacy), Head of the Laboratory of Bioinformatics and Pharmacological Modeling at the Center for Biopharmaceutical Analysis and Metabolic Research, Institute of Translational Medicine and Biotechnology, I.M. Sechenov First Moscow State Medical University (Sechenov University). </p><p>2 Trubetskaya Str., Bldg 8, Moscow, Russia, 119991.</p></bio><email xlink:type="simple">shestakova_k_m@staff.sechenov.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-9394-7994</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Тарасов</surname><given-names>В. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Tarasov</surname><given-names>V. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>доктор фармацевтических наук, доцент по специальности «Фармакология, клиническая фармакология», директор Института трансляционной медицины и биотехнологии, проректор по научно-технологическому развитию ФГАОУ ВО Первый МГМУ им. И.М. Сеченова Минздрава России (Сеченовский университет). </p><p>Россия, 119991, г. Москва, ул. Трубецкая, д. 8, стр. 2.</p></bio><bio xml:lang="en"><p>Doctor of Sciences (Pharmacy), Director of the Institute of Translational Medicine and Biotechnology, Vice-Rector for Scientific and Technological Development, I.M. Sechenov First Moscow State Medical University (Sechenov University).</p><p>2 Trubetskaya Str., Bldg 8, Moscow, Russia, 119991.</p></bio><email xlink:type="simple">tarasov_v_v_2@staff.sechenov.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-2615-7167</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Смолярчук</surname><given-names>Е. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Smolyarchuk</surname><given-names>E. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат медицинских наук, доцент, заведующий кафедрой фармакологии Института Фармации им. А.П. Нелюбина ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова» Минздрава России (Сеченовский Университет).</p><p>Россия, 119991, г. Москва, ул. Трубецкая, д. 8, стр. 2.</p></bio><bio xml:lang="en"><p>Candidate of Sciences (Medicine), Assistant Professor, Head of the Department of Pharmacology of the A.P. Nelyubin Institute of Pharmacy, I.M. Sechenov First Moscow State Medical University (Sechenov University). </p><p>2 Trubetskaya Str., Bldg 8, Moscow, Russia, 119991.</p></bio><email xlink:type="simple">smolyarchuk_e_a@staff.sechenov.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-1878-4467</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кудлай</surname><given-names>Д. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Kudlay</surname><given-names>D. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>доктор медицинских наук, член-корреспондент РАН, профессор кафедры фармакологии Института Фармации им. А.П. Нелюбина ФГАОУ ВО «Первый МГМУ им. И.М. Сеченова» Минздрава России (Сеченовский Университет); заместитель декана по научно-технологическому развитию факультета биоинженерии и биоинформатики, старший научный сотрудник факультета биоинженерии и биоинформатики МГУ им. М.В. Ломоносова; ведущий научный сотрудник лаборатории персонализированной медицины и молекулярной иммунологии № 71 ФГБУ «ГНЦ Институт иммунологии» ФМБА России. </p><p>1. Россия, 119991, г. Москва, ул. Трубецкая, д. 8, стр. 2.</p><p>2. Россия, 119991, г. Москва, Ленинские горы, д. 1.</p><p>3. Россия, 115522, г. Москва, Каширское шоссе, д. 24.</p></bio><bio xml:lang="en"><p>Doctor of Sciences (Medicine), Professor of the Department of Pharmacology at the A.P. Nelyubin Institute of Pharmacy, I.M. Sechenov First Moscow State Medical University (Sechenov University); Deputy Dean for Scientific and Technological Development of the Faculty of Bioengineering and Bioinformatics, Senior Researcher at the Faculty of Bioengineering and Bioinformatics, Lomonosov Moscow State University; Leading Researcher of the Laboratory of Personalized Medicine and Molecular Immunology No. 71, State Research Center Institute of Immunology; Corresponding Member of the Russian Academy of Sciences. </p><p>1. 2 Trubetskaya Str., Bldg 8, Moscow, Russia, 119991.</p><p>2. 1 Leninskie Gory, Moscow, Russia, 119991.</p><p>3. 24 Kashirskoe Hwy, Moscow, 115522, Russia.</p></bio><email xlink:type="simple">kudlay_d_a@staff.sechenov.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-9032-1558</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Апполонова</surname><given-names>С. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Apollonova</surname><given-names>S. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат химических наук, руководитель Центра биофармацевтического анализа и метаболомных исследований, Институт трансляционной медицины и биотехнологии, ФГАОУ ВО Первый МГМУ им. И.М. Сеченова Минздрава России (Сеченовский университет). </p><p>Россия, 119991, г. Москва, ул. Трубецкая, д. 8, стр. 2.</p></bio><bio xml:lang="en"><p>Candidate of Sciences (Chemistry), Head of the Center for Biopharmaceutical Analysis and Metabolic Research at the Institute of Translational Medicine and Biotechnology, I.M. Sechenov First Moscow State Medical University (Sechenov University). </p><p>2 Trubetskaya Str., Bldg 8, Moscow, Russia, 119991.</p></bio><email xlink:type="simple">appolonova_s_a@staff.sechenov.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет имени И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет).</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Sechenov First Moscow State Medical University (Sechenov University).</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>1. Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет имени И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет).&#13;
2. Федеральное государственное бюджетное образовательное учреждение высшего образования «Московский государственный университет имени М.В. Ломоносова».&#13;
3. Федерального государственного бюджетного учреждения «Государственный научный центр “Институт иммунологии”» Федерального медико-биологического агентства.</institution><country>Россия</country></aff><aff xml:lang="en"><institution>1. Sechenov First Moscow State Medical University (Sechenov University).&#13;
2. Lomonosov Moscow State University.&#13;
3. State Research Center Institute of Immunology.</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>04</day><month>09</month><year>2025</year></pub-date><volume>13</volume><issue>4</issue><fpage>246</fpage><lpage>259</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Резванов П.М., Москалева Н.Е., Шестакова К.М., Тарасов В.В., Смолярчук Е.А., Кудлай Д.А., Апполонова С.А., 2025</copyright-statement><copyright-year>2025</copyright-year><copyright-holder xml:lang="ru">Резванов П.М., Москалева Н.Е., Шестакова К.М., Тарасов В.В., Смолярчук Е.А., Кудлай Д.А., Апполонова С.А.</copyright-holder><copyright-holder xml:lang="en">Rezvanov P.M., Moskaleva N.E., Shestakova K.M., Tarasov V.V., Smolyarchuk E.A., Kudlay D.A., Apollonova S.A.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.pharmpharm.ru/jour/article/view/1710">https://www.pharmpharm.ru/jour/article/view/1710</self-uri><abstract><sec><title>Цель</title><p>Цель. Разработка и валидация отечественного программного обеспечения для некомпартментного анализа (НКА) фармакокинетических данных, сопоставимого по точности и функциональности с признанным зарубежным программным обеспечением Phoenix WinNonlin (США).</p></sec><sec><title>Материалы и методы</title><p>Материалы и методы. Веб-приложение PreKinetix реализовано на языке программирования Python с использованием фреймворка Streamlit. Алгоритмы расчёта фармакокинетических параметров (максимальная концентрация [Cmax], площадь под фармакокинетической кривой [AUC], период полувыведения [T1/2], среднее время пребывания [MRT] и др.) основаны на методиках референсного программного обеспечения Phoenix WinNonlin (Certara, США), использованного для сравнения и широко применяемого в международной практике. Поддерживаются три модели однократного введения лекарственного средства: внутривенное болюсное, внутривенная инфузия и внесосудистое введение. Для верификации использованы литературные и экспериментальные данные, охватывающие более 450 фармакокинетических профилей.</p></sec><sec><title>Результаты</title><p>Результаты. Расчёты, выполненные с помощью PreKinetix, показали полное совпадение с результатами Phoenix WinNonlin с относительной ошибкой менее 0,0001% по всем основным параметрам. Программа устойчиво обрабатывает нулевые и пропущенные значения, автоматически исключает некорректные записи, визуализирует фармакокинетические профили в линейной и полулогарифмической шкалах, формирует отчёты в форматах .xlsx* и .docx*. Интерфейс приложения позволяет использовать его не только специалистам, но и менее подготовленным пользователям.</p></sec><sec><title>Заключение</title><p>Заключение. PreKinetix представляет собой отечественный инструмент для НКА, объединяющий точность, автоматизацию, доступность и удобство. Он может применяться в доклинических и ранних фазах клинических исследований, а также в образовательных целях для подготовки специалистов в области фармакокинетики и биофармацевтики.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>The aim</title><p>The aim. Development and validation of domestic software for non-compartmental analysis (NCA) of pharmacokinetic data, comparable in accuracy and functionality to the recognized foreign software Phoenix WinNonlin (USA).</p></sec><sec><title>Materials and methods</title><p>Materials and methods. The PreKinetix web application is implemented in the Python programming language using the Streamlit framework. Algorithms for calculating pharmacokinetic parameters (maximum concentration [Cmax], area under the pharmacokinetic curve [AUC], half-life [T1/2], mean residence time [MRT], etc.) are based on the methods of the reference software Phoenix WinNonlin (Certara, USA), used for comparison and are widely used in international practice. Three models of single drug administration are supported: intravenous bolus, intravenous infusion, and extravascular administration. Literary and experimental data covering more than 450 pharmacokinetic profiles were used for verification.</p></sec><sec><title>Results</title><p>Results. Calculations performed using PreKinetix showed complete agreement with the results of Phoenix WinNonlin with a relative error of less than 0.0001% for all main parameters. The program stably processes zero and missing values, automatically excludes incorrect records, visualizes pharmacokinetic profiles in linear and semi-logarithmic scales, and generates reports in .xlsx* and .docx* formats. The application interface allows it to be used not only by specialists but also by less trained users.</p></sec><sec><title>Conclusion</title><p>Conclusion. PreKinetix is a domestic tool for NCA that combines accuracy, automation, accessibility, and convenience. It can be used in preclinical and early phases of clinical trials, as well as in educational settings for training specialists in pharmacokinetics and biopharmaceutics.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>фармакокинетический анализ</kwd><kwd>доклинические исследования</kwd><kwd>некомпартментный анализ</kwd><kwd>фармакокинетика</kwd><kwd>биофармацевтические исследования</kwd><kwd>программное обеспечение</kwd><kwd>фармацевтическая разработка</kwd></kwd-group><kwd-group xml:lang="en"><kwd>pharmacokinetic analysis</kwd><kwd>preclinical studies</kwd><kwd>non-compartmental analysis</kwd><kwd>pharmacokinetics</kwd><kwd>biopharmaceutical research</kwd><kwd>software</kwd><kwd>pharmaceutical development</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Работа выполнена в рамках государственного задания № Государственной регистрации 124031100079-6, Тема НИОКР(ПНИЭР): «Разработка цифровых моделей прогнозирования органотоксичности лекарственных средств на основе данных метаболомного анализа с использованием альтернативной биологической модели».</funding-statement><funding-statement xml:lang="en">The work was performed within the framework of the state assignment No. 124031100079-6, the topic of R&amp;D (PNER): "Development of digital models for predicting drug organotoxicity based on data from metabolomic analysis using an alternative biological model."</funding-statement></funding-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Kim H., Han S., Cho Y.S., Yoon S.K., Bae K.S. 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