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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">safetyrisk</journal-id><journal-title-group><journal-title xml:lang="ru">Безопасность и риск фармакотерапии</journal-title><trans-title-group xml:lang="en"><trans-title>Safety and Risk of Pharmacotherapy</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2312-7821</issn><issn pub-type="epub">2619-1164</issn><publisher><publisher-name>Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">safetyrisk-19</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>ОБЗОРЫ И ОРИГИНАЛЬНЫЕ СТАТЬИ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>REVIEWS AND ORIGINAL ARTICLES</subject></subj-group></article-categories><title-group><article-title>Мониторинг безопасности зарегистрированных лекарственных средств у беременных: фармакогенетические аспекты</article-title><trans-title-group xml:lang="en"><trans-title>Monitoring post-approval drug safety in pregnancy: pharmacogenetic aspects</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>Сокова</surname><given-names>Елена Александровна</given-names></name></name-alternatives><email xlink:type="simple">Sokova2@rambler.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff xml:lang="ru" id="aff-1"><institution>Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации</institution><country>Russian Federation</country></aff><pub-date pub-type="collection"><year>2015</year></pub-date><pub-date pub-type="epub"><day>20</day><month>02</month><year>2018</year></pub-date><volume>0</volume><issue>3</issue><fpage>30</fpage><lpage>35</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Сокова Е.А., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">Сокова Е.А.</copyright-holder><copyright-holder xml:lang="en">Сокова Е.А.</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.risksafety.ru/jour/article/view/19">https://www.risksafety.ru/jour/article/view/19</self-uri><abstract><p>В статье рассматриваются новые фармакогенетические подходы в оценке безопасности применения зарегистрированных лекарственных средств при беременности, позволяющие прогнозировать риски фармакотерапии как для беременной женщины, так и для плода при проведении фармаконадзора.</p></abstract><trans-abstract xml:lang="en"><p>The purpose of this article is to describe and to examine the utility of new pharmacogenetic approaches in monitoring post-approval drug safety in pregnancy. Data on gene expression in pregnancy and metabolic variation may, in specific instances, help to predict adverse drug reactions in the mother-placenta-fetus complex and to identify individuals at a higher risk.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>беременность</kwd><kwd>лекарственное средство</kwd><kwd>безопасность</kwd><kwd>фармакогенетика</kwd><kwd>фармаконадзор</kwd><kwd>pregnancy</kwd><kwd>drugs</kwd><kwd>safety</kwd><kwd>pharmacogenetics</kwd><kwd>pharmacovigilance</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">Advances in FDA’s Safety Program for Marketed Drugs. Drug Safety Report April 2012. Center for Drug Evaluation and Research U.S. Food and Drug Administration U.S. Health and Human Services A.</mixed-citation><mixed-citation xml:lang="en">Advances in FDA’s Safety Program for Marketed Drugs. Drug Safety Report April 2012. 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