vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)vedomostiregmed-133Research ArticleОБЗОРЫREVIEWSПланирование и оценка исследований биоэквивалентности препаратов розувастатинаPlanning and evaluation of bioequivalence studies of rosuvastatin drug productsРомодановскийД. П.RomodanovskyD. P.noemail@neicon.ruГорячевД. В.GoryachevD. V.noemail@neicon.ruНЦ экспертизы средств медицинского примененияРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation20171302201873142149Copyright © Ромодановский Д.П., Горячев Д.В., 20182018Ромодановский Д.П., Горячев Д.В.Romodanovsky D.P., Goryachev D.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/133

В статье представлены результаты ретроспективного анализа исследований биоэквивалентности воспроизведенных препаратов розувастатина отечественного и зарубежного производства с целью унификации подходов к проведению исследований биоэквивалентности розувастатина в Российской Федерации. Описаны существующие в настоящее время регуляторные рекомендации и подходы к изучению биоэквивалентности воспроизведенных препаратов, в частности препаратов розувастатина, высоковариабельных лекарственных препаратов, сформулированы рекомендации в отношении дизайна и оценки результатов исследований препаратов розувастатина.

The article reviews bioequivalence studies of Russian and foreign generic rosuvastatin preparations with the goal of harmonizing approaches to rosuvastatin bioequivalence studies in the Russian Federation. The article describes the current regulatory recommendations for and approaches to bioequivalence studies of generic drugs (and in particular of rosuvastatin preparations which are highly variable drugs) and gives recommendations on the design of rosuvastatin studies and evaluation of results.

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The authors declare that there are no conflicts of interest present.