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-61Research ArticleКЛИНИЧЕСКАЯ ФАРМАКОЛОГИЯCLINICAL PHARMACOLOGYКлинические исследования лекарственных средств у беременных: отношение ожидаемой пользы к возможному риску?Clinical trials in pregnancy: evaluation of benefit/risk?СоковаЕ. А.SokovaE. A.sokova2@rambler.ruБунятянН. Д.BunyatyanN. D.noemail@neicon.ruМазеркинаИ. А.MazerkinaI. A.noemail@neicon.ruДемидоваО. А.DemidovaO. A.noemail@neicon.ruАлександроваТ. В.AleksandrovaT. V.noemail@neicon.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияFederal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationRussian Federation201513022018042631Copyright © Сокова Е.А., Бунятян Н.Д., Мазеркина И.А., Демидова О.А., Александрова Т.В., 20182018Сокова Е.А., Бунятян Н.Д., Мазеркина И.А., Демидова О.А., Александрова Т.В.Sokova E.A., Bunyatyan N.D., Mazerkina I.A., Demidova O.A., Aleksandrova T.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/61

С точки зрения фармакотерапии беременность представляет собой специфическую фазу жизни, которая отличается от всех других фаз жизни по медицинским, этическим и правовым основам. В статье рассматриваются научные, этические и некоторые регуляторные принципы включения беременных женщин в клинические исследования лекарственных средств, обосновывается необходимость их проведения с позиции клинической фармакологии. Клиническая ценность исследований по оценке отношения ожидаемой пользы к возможному риску при проведении фармакотерапии у беременных диктует необходимость развития данного научного направления.

In terms of pharmacotherapy, pregnancy is a specific phase of life that is different from all the other phases of the life of medical, ethical and legal framework. The article examines the scientific, ethical and regulatory principles of inclusion of pregnant women in the clinical trials of drugs, the necessity for them is justified from the point of clinical pharmacology. The clinical value assessment studies regarding the expected benefits to the possible risks during the pharmacotherapy in pregnancy necessitates the development of this scientific direction.

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