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-115Research ArticleРАЦИОНАЛЬНОЕ ПРИМЕНЕНИЕ ЛЕКАРСТВЕННЫХ ПРЕПАРАТОВRATIONAL USE OF MEDICINESВзаимозаменяемость препаратов левотироксинаInterchangeability of levothyroxine sodium tabletsГородецкаяГ. И.GorodetskayaG. I.noemail@neicon.ruСоковаЕ. А.SokovaE. A.noemail@neicon.ruМуслимоваО. В.MuslimovaO. V.noemail@neicon.ruАлександроваТ. В.AleksandrovaT. V.noemail@neicon.ruМазеркинаИ. А.MazerkinaI. A.noemail@neicon.ruРудневС. Г.RudnevS. G.noemail@neicon.ruНаучный центр экспертизы средств медицинского примененияРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation201713022018713340Copyright © Городецкая Г.И., Сокова Е.А., Муслимова О.В., Александрова Т.В., Мазеркина И.А., Руднев С.Г., 20182018Городецкая Г.И., Сокова Е.А., Муслимова О.В., Александрова Т.В., Мазеркина И.А., Руднев С.Г.Gorodetskaya G.I., Sokova E.A., Muslimova O.V., Aleksandrova T.V., Mazerkina I.A., Rudnev S.G.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/115

Подготовлен обзор данных литературы и нормативных документов по безопасному и эффективному использованию препаратов левотироксина, который имеет менее чем двукратное различие между минимальной токсической дозой и минимальной эффективной концентрацией в крови. Рассмотрена проблема замены препаратов левотироксина, которые могут проявлять терапевтическую неэквивалентность при подтвержденной биоэквивалентности. Представлены результаты исследований взаимозаменяемости препаратов левотироксина в различных странах. Сформулирована необходимость совершенствования системы координации производства и клинического использования препаратов левотироксина, что в перспективе позволит достичь соответствия воспроизведенных препаратов референтным.

The article reviews scientific literature and regulatory documents on safe and efficacious use of levothyroxine medicines. Levothyroxine has less than a twofold difference between the minimal toxic concentration and minimal effective concentration. The article discusses the issue of switching between levothyroxine medicines that can be therapeutically nonequivalent while having proven bioequivalence. The article reviews results of levothyroxine medicines interchangeability studies in different countries. The authors assert the need for improving the coordination of manufacturing and the clinical use of levothyroxine medicines, which will help achieve the equivalence of generic and innovator medicines in the future.

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