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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">phgenomics</journal-id><journal-title-group><journal-title xml:lang="ru">Фармакогенетика и фармакогеномика</journal-title><trans-title-group xml:lang="en"><trans-title>Pharmacogenetics and Pharmacogenomics</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2588-0527</issn><issn pub-type="epub">2686-8849</issn><publisher><publisher-name>LLC "Izdatelstvo OKI"</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">phgenomics-165</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>ФАРМАКОГЕНЕТИЧЕСКИЕ ИССЛЕДОВАНИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>PHARMACOGENETICS STUDY</subject></subj-group></article-categories><title-group><article-title>Фармакогенетика и клинические исследования: точки соприкосновения</article-title><trans-title-group xml:lang="en"><trans-title>Pharmacogenetics and clinical studies: common ground</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Казаков</surname><given-names>Р. Е.</given-names></name><name name-style="western" xml:lang="en"><surname>Kazakov</surname><given-names>R. E.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Казаков Руслан Евгеньевич — к.б.н., начальник отдела Персонализированной медицины и клинической фармакогенетики.</p><p>г. Москвател.: +7 (926) 423-90-37 </p></bio><email xlink:type="simple">rustic100@rambler.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Бердникова</surname><given-names>Н. Г.</given-names></name><name name-style="western" xml:lang="en"><surname>Berdnikova</surname><given-names>N. G.</given-names></name></name-alternatives><bio xml:lang="ru"><p>г. Москва</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Сычёв</surname><given-names>Д. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Sychev</surname><given-names>D. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>г. Москва</p></bio><xref ref-type="aff" rid="aff-3"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru">Федеральное государственное бюджетное учреждение Научный центр экспертизы средств медицинского применения Министерства здравоохранения РФ<country>Россия</country></aff><aff xml:lang="en">Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru">ГБОУ ВПО Первый Московский государственный медицинский университет им. И.М. Сеченова Минздрава России; ГБУЗ Городская клиническая больница им. И.В. Давыдовского Департамента здравоохранения<country>Россия</country></aff><aff xml:lang="en">I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation; I.M. Davidovckiy City Clinical Hospital №23<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru">Государственное бюджетное образовательное учреждение дополнительного профессионального образования Российская медицинская академия последипломного образования Министерства здравоохранения РФ<country>Россия</country></aff><aff xml:lang="en">State Funded Educational Institution Russian Medical Academy of Postgraduate Education Studies of the Ministry of Health of the Russian Federation<country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2016</year></pub-date><pub-date pub-type="epub"><day>25</day><month>03</month><year>2020</year></pub-date><volume>0</volume><issue>1</issue><fpage>18</fpage><lpage>23</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Казаков Р.Е., Бердникова Н.Г., Сычёв Д.А., 2020</copyright-statement><copyright-year>2020</copyright-year><copyright-holder xml:lang="ru">Казаков Р.Е., Бердникова Н.Г., Сычёв Д.А.</copyright-holder><copyright-holder xml:lang="en">Kazakov R.E., Berdnikova N.G., Sychev D.A.</copyright-holder><license 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.pharmacogenetics-pharmacogenomics.ru/jour/article/view/165">https://www.pharmacogenetics-pharmacogenomics.ru/jour/article/view/165</self-uri><abstract><p>Фармакогенетика и клинические исследования на протяжении десятилетий развивались независимо. Однако в настоящее время становится очевидным, что для гарантии эффективного и безопасного лечения необходимо включение в клинические исследования генетического тестирования и привлечение знаний, накопленных в ходе фармакогенетических исследований. С помощью генетического тестирования можно на начальных этапах клинических исследований исключить из опытной группы добровольцев и/или пациентов, отличающихся по фармакокинетическим и фармакодинамическим показателям от средних показателей; на поздних фазах, наоборот, изучить эффективность и безопасность на выборках пациентов с генетически детерминированными отличиями от нормы.</p></abstract><trans-abstract xml:lang="en"><p>Pharmacogenetics and clinical trials developed independently for decades. Nowadays it becomes apparent that genetic testing and the pharmacogenetic are necessary for the clinical studies to ensure effective and safe treatment. At the initial stages of clinical trials of the experimental groups we exclude volunteers and/or patients who have pharmacokinetic and pharmacodynamic differences by genetic testing. Conversely, later phases of clinical trials we to examine the efficacy and safety in the samples of patients with genetically determined differences from the norm.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>фармакогенетика</kwd><kwd>генотипирование</kwd><kwd>генетические биомаркеры</kwd><kwd>однонуклеотидные полиморфизмы</kwd><kwd>клинические исследования</kwd></kwd-group><kwd-group xml:lang="en"><kwd>pharmacogenetics</kwd><kwd>pharmacogenomic testing</kwd><kwd>genomic biomarkers</kwd><kwd>single nucleotide polymorphism</kwd><kwd>clinical trials</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Клиническая фармакогенетика / под общ. ред. В.Г. Кукеса, Н.П. Бочкова. 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