phkineticaФармакокинетика и ФармакодинамикаPharmacokinetics and Pharmacodynamics2587-78362686-8830ООО «Издательство ОКИ»phkinetica-138Research ArticleТЕОРЕТИЧЕСКИЕ ОСНОВЫTHEORETICAL BASISПравила проведения исследований биоаналоговых лекарственных средств (биоаналогов)Guidelines of research biosimilar drugsИвановРоманIvanovR. .noemail@neicon.ruСекарёваГалинаSekarnvaG. .noemail@neicon.ruКравцоваОльгаKravtsovaO. .noemail@neicon.ruКудлайДмитрийKudlayD. .noemail@neicon.ruЛукьяновСергейLukyanovS. .noemail@neicon.ruТихоноваИринаTikhonovaI. .noemail@neicon.ruДёминАлександрDeminA. .noemail@neicon.ruМаксумоваЛолаMaksumovaL. .noemail@neicon.ruНикитинаИринаNikitinaI. .noemail@neicon.ruОбуховАлександрObukhovA. .noemail@neicon.ruЗайцевДмитрийZaitsevD. .noemail@neicon.ruСтепановАлексейStepanovA. .noemail@neicon.ruНосыреваМаринаNosyrevaM. .noemail@neicon.ruСамсоновМихаилSamsonovM. .noemail@neicon.ruЗАО «БИОКАД»Russian FederationЗАО «Генериум»Russian FederationЗАО «ФармФирма «Сотекс»Russian FederationООО «БиоИнтегратор» (группа компаний ЦВТ «ХимРар»)Russian FederationГруппа Компаний «ГЕРОФАРМ»Russian FederationЗАО «Фарм-Холдинг» группы компаний «ГЕРОФАРМ»Russian FederationОАО «Фармстандарт»Russian FederationЗАО «Р-Фарм»Russian Federation201409042014012136Copyright © Иванов Р..., Секарёва Г..., Кравцова О..., Кудлай Д..., Лукьянов С..., Тихонова И..., Дёмин А..., Максумова Л..., Никитина И..., Обухов А..., Зайцев Д..., Степанов А..., Носырева М..., Самсонов М..., 20142014Иванов Р., Секарёва Г., Кравцова О., Кудлай Д., Лукьянов С., Тихонова И., Дёмин А., Максумова Л., Никитина И., Обухов А., Зайцев Д., Степанов А., Носырева М., Самсонов М.Ivanov R..., Sekarnva G..., Kravtsova O..., Kudlay D..., Lukyanov S..., Tikhonova I..., Demin A..., Maksumova L..., Nikitina I..., Obukhov A..., Zaitsev D..., Stepanov A..., Nosyreva M..., Samsonov M...Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmacokinetica.ru/jour/article/view/138GLPICHархивирование данныхбиоаналогдоклинические исследованиядоклиническое исследование иммуногенностииммуногенностьинновационный биологический лекарственный препаратинсулининтерферон бетаисследования безопасностиисследования эффективностиисследования фармакокинетикиклинические исследованиямоноклональные антителаоригинальный биологический лекарственный препаратпострегистрационные исследованияпострегистрационный мониторинг безопасностиправила проведения исследованийсообщения о серьёзных нежелательных реакцияхтоксикологические исследованиятоксичностьфармакодинамикафармакодинамические исследованияфармакокинетические исследованияфармаконадзорэквивалентностьReferencesEMA. 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The authors declare that there are no conflicts of interest present.