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-44Research ArticleЭКСПЕРТИЗА ЛЕКАРСТВЕННЫХ СРЕДСТВEXPERT EVALUATION OF MEDICINESОсобенности проведения исследования биоэквивалентности лекарственных препаратов -аналогов эндогенных соединенийSpecific features of the bioequivalence study of drugs - analogs of endogenous compoundsАдонинВладимир КонстантиновичAdoninV. K.Adonin@expmed.ruРомодановскийДмитрий ПавловичRomodanovskiyD. P.noemail@neicon.ruНиязовРавиль РашидовичNiyazovR. R.noemail@neicon.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationRussian Federation2015130220180337Copyright © Адонин В.К., Ромодановский Д.П., Ниязов Р.Р., 20182018Адонин В.К., Ромодановский Д.П., Ниязов Р.Р.Adonin V.K., Romodanovskiy D.P., Niyazov R.R.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/44

Проведен анализ требований к проведению исследований биоэквивалентности (БЭ) лекарственных препаратов - аналогов эндогенных соединений (ЛП-аЭС) ведущих мировых регуляторов: Администрации по пищевым продуктам и лекарственным препаратам США (FDA), Европейского агентства по лекарственным средствам (EMA); и проекта требований Евразийского экономического союза. Проанализированы данные научной литературы по вопросам исследований БЭ и результаты проведенных экспертиз протоколов и отчетов клинических исследований БЭ ЛП-аЭС, поступавших в ФГБУ «НЦЭСМП» Минздрава России за период 2013-2015 гг. На основании результатов проведенного анализа международных требований, данных литературы по изучаемому вопросу и имеющегося отечественного опыта проведения и оценки протоколов и отчетов предложены общие рекомендации для проведения исследований БЭ ЛП-аЭС и предоставления полученных результатов.

This paper presents an analysis of leading foreign regulatory authorities’ requirements for the bioequivalence studies of medicinal products containing analogues of endogenous substances. US Food and Drug Administration, European Medicines Agency, and Eurasian Economic Union’s approaches are discussed. The scientific literature on the bioequivalence studies of endogenous substances, as well as the results of clinical trial and marketing authorization applications assessments which were conducted by the FSBI “SCEEMP” in 2013-2015 are analyzed. General recommendations and principles for design and conduction of the bioequivalence studies of such medicinal products and reporting of their results are proposed, basing on the results of analysis of the foreign requirements, scientific data and domestic experience.

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