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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">pulmo</journal-id><journal-title-group><journal-title xml:lang="ru">Пульмонология</journal-title><trans-title-group xml:lang="en"><trans-title>PULMONOLOGIYA</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">0869-0189</issn><issn pub-type="epub">2541-9617</issn><publisher><publisher-name>Scientific and Practical Journal “PULMONOLOGIYA” LLC</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">pulmo-92</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>КЛИНИЧЕСКАЯ ФАРМАКОЛОГИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>CLINICAL PHARMACOLOGY</subject></subj-group></article-categories><title-group><article-title>Воспроизведенные ингаляционные лекарственные средства: как оценить их свойства?</article-title><trans-title-group xml:lang="en"><trans-title>Generic inhaled drugs: how to evaluate their properties?</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>Зырянов</surname><given-names>С. К.</given-names></name><name name-style="western" xml:lang="en"><surname>Zyryanov</surname><given-names>S. K.</given-names></name></name-alternatives><bio xml:lang="ru"><p>д. м. н., проф. кафедры клинической фармакологии </p><p>117437, Москва, ул. Островитянова, 1. Тел.: (499) 261-25-90.</p></bio><email xlink:type="simple">serguei-kensarin@hotbox.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>Айсанов</surname><given-names>З. Р.</given-names></name><name name-style="western" xml:lang="en"><surname>Aisanov</surname><given-names>Z. R.</given-names></name></name-alternatives><bio xml:lang="ru"><p>д. м. н., проф., зав. отделом клинической физиологии и клинических исследований </p><p>105077, Москва, ул. 11-я Парковая, 32, корп. 4. Тел.: (495) 965-34-66.</p></bio><email xlink:type="simple">aisanov@mail.ru</email><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff xml:lang="ru" id="aff-1"><institution>ГБОУ ВПО "Российский национальный исследовательский медицинский университет им. Н.И.Пирогова"</institution><country>Russian Federation</country></aff><aff xml:lang="ru" id="aff-2"><institution>ФГУ "НИИ пульмонологии" ФМБА России</institution><country>Russian Federation</country></aff><pub-date pub-type="collection"><year>2012</year></pub-date><pub-date pub-type="epub"><day>28</day><month>06</month><year>2012</year></pub-date><volume>0</volume><issue>3</issue><fpage>115</fpage><lpage>118</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Зырянов С.К., Айсанов З.Р., 2012</copyright-statement><copyright-year>2012</copyright-year><copyright-holder xml:lang="ru">Зырянов С.К., Айсанов З.Р.</copyright-holder><copyright-holder xml:lang="en">Zyryanov S.K., Aisanov Z.R.</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://journal.pulmonology.ru/pulm/article/view/92">https://journal.pulmonology.ru/pulm/article/view/92</self-uri><abstract><p>Воспроизведенные ингаляционные лекарственные средства: как оценить их свойства?</p></abstract><trans-abstract xml:lang="en"><p>Generic inhaled drugs: how to evaluate their properties?</p></trans-abstract><kwd-group xml:lang="ru"><kwd>генерик</kwd><kwd>фармацевтическая эквивалентность</kwd></kwd-group><kwd-group xml:lang="en"><kwd>generic</kwd><kwd>pharmaceutical equivalence</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">FDA. Orange book: Approved drug products with therapeutic equivalence evaluations. 30th ed.; 2010.</mixed-citation><mixed-citation xml:lang="en">FDA. Orange book: Approved drug products with therapeutic equivalence evaluations. 30th ed.; 2010.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Белоусов Ю.Б., Зырянов С.К. Дженерики и бренды: pro et contra. Качеств. клини. практ. 2003; 2: 95–100.</mixed-citation><mixed-citation xml:lang="en">Белоусов Ю.Б., Зырянов С.К. Дженерики и бренды: pro et contra. Качеств. клини. практ. 2003; 2: 95–100.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Daley'Yates P.T., Parkins D.A. Establishing bioequivalence for inhaled drug, weighing the evidence. Expert. Opin. Drug Deliv. 2011; 1: 112.</mixed-citation><mixed-citation xml:lang="en">Daley'Yates P.T., Parkins D.A. Establishing bioequivalence for inhaled drug, weighing the evidence. Expert. Opin. Drug Deliv. 2011; 1: 112.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">European Medicines Agency. Committee for Medicinal Products for Human Use. Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents Doc. Ref. CPMP/ EWP/4151/00 Rev. 1. Jan. 2009. London; 2009.</mixed-citation><mixed-citation xml:lang="en">European Medicines Agency. Committee for Medicinal Products for Human Use. Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents Doc. Ref. CPMP/ EWP/4151/00 Rev. 1. Jan. 2009. London; 2009.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Lawrence M., Wolfe J., Webb D.R. et al. Efficacy of inhaled fluticasone propionate in asthma results from topical and not from systemic activity. Am. J. Respir. Crit. Care Med. 1997; 156: 744–751.</mixed-citation><mixed-citation xml:lang="en">Lawrence M., Wolfe J., Webb D.R. et al. Efficacy of inhaled fluticasone propionate in asthma results from topical and not from systemic activity. Am. J. Respir. Crit. Care Med. 1997; 156: 744–751.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Clearie K.I., Williamson P.A., Vaidyanathan S. et al. Systemic bioavailability of hydrofluoroalkane formulation of fluticasone / salmeterol in healthy volunteers via pMDI alone and spacer. Br. J. Clin. Pharmacol. 2010; 69: 637–644.</mixed-citation><mixed-citation xml:lang="en">Clearie K.I., Williamson P.A., Vaidyanathan S. et al. Systemic bioavailability of hydrofluoroalkane formulation of fluticasone / salmeterol in healthy volunteers via pMDI alone and spacer. Br. J. Clin. Pharmacol. 2010; 69: 637–644.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Информационное письмо-обращение экспертов Российского респираторного общества к врачам первичного звена и специалистам в области пульмонологии. Пульмонология 2011; 6; 119.</mixed-citation><mixed-citation xml:lang="en">Информационное письмо-обращение экспертов Российского респираторного общества к врачам первичного звена и специалистам в области пульмонологии. Пульмонология 2011; 6; 119.</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
