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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">clinvest</journal-id><journal-title-group><journal-title xml:lang="ru">Качественная клиническая практика</journal-title><trans-title-group xml:lang="en"><trans-title>Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2588-0519</issn><issn pub-type="epub">2618-8473</issn><publisher><publisher-name>ООО «Издательство ОКИ</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">clinvest-397</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>ФАРМАКОЭКОНОМИКА</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>PHARMACOECONOMICS</subject></subj-group></article-categories><title-group><article-title>Сравнительная характеристика препаратов ванкомицина, зарегистрированных в РФ</article-title><trans-title-group xml:lang="en"><trans-title></trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-2164-8290</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Белоусов</surname><given-names>Д. Ю.</given-names></name></name-alternatives><bio xml:lang="ru"><p>генеральный директор</p><p>SPIN-код: 6067-9067</p></bio><email xlink:type="simple">clinvest@mail.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>Белоусов</surname><given-names>Ю. Б.</given-names></name></name-alternatives><email xlink:type="simple">clinvest@mail.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Селютин</surname><given-names>О. А.</given-names></name></name-alternatives><email xlink:type="simple">clinvest@mail.ru</email></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Филиппова</surname><given-names>О. В.</given-names></name></name-alternatives><email xlink:type="simple">clinvest@mail.ru</email></contrib></contrib-group><aff xml:lang="ru" id="aff-1"><institution>ООО "Центр фармакоэкономических исследований", г. Москва</institution><country>Russian Federation</country></aff><aff xml:lang="ru" id="aff-2"><institution>ГОУ ВПО «Российский национальный исследовательский медицинский университет имени Н.И. Пирогова», Москва</institution><country>Russian Federation</country></aff><pub-date pub-type="collection"><year>2009</year></pub-date><pub-date pub-type="epub"><day>06</day><month>07</month><year>2018</year></pub-date><volume>0</volume><issue>4</issue><elocation-id>397</elocation-id><permissions><copyright-statement>Copyright &amp;#x00A9; Белоусов Д.Ю., Белоусов Ю.Б., Селютин О.А., Филиппова О.В., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">Белоусов Д.Ю., Белоусов Ю.Б., Селютин О.А., Филиппова О.В.</copyright-holder><copyright-holder xml:lang="en">Белоусов Д.Ю., Белоусов Ю.Б., Селютин О.А., Филиппова О.В.</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.clinvest.ru/jour/article/view/397">https://www.clinvest.ru/jour/article/view/397</self-uri><abstract><p>Целью настоящей работы явилась экспертная оценка эквивалентности требований к качеству препаратов ванкомицина (по состоянию на 15 сентября 2008 г.):</p><p>Необходимостью в проведении этого исследования являлось то, что при регистрации лекарственных препаратов каждый производитель дженерика регистрирует собственный вариант требуемой документации. В результате требования к качеству различных дженериков могут быть различны. Анализ нормативной документации (НД) проводился с использованием инструкций к препаратам и паспортов качества.</p><p>Программа исследования проводилась по следующему алгоритму:</p><sec><title>Материалы и методы</title><p>Материалы и методы</p><p>В ходе исследования был проведен расширенный информационный поиск в биомедицинских базах данных Embase, RxList, MedWatch, Cochrane Collaboration, списках литературы оригинальных обзоров и статей; производился анализ реферативных данных; отбирались публикации, содержащие информацию о клинических исследованиях, обзоры о применении ванкомицина и его побочных эффектах.</p><p>Анализ нормативной документации проводился по базе данных Воронежского ЦККиСЛС, с использованием инструкций к препаратам и паспортов качества.</p></sec></abstract><kwd-group xml:lang="ru"><kwd>фармэкспертиза</kwd><kwd>ванкомицин</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">Griffith R.S. 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