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Неврология, нейропсихиатрия, психосоматика

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Воспроизведенные лекарственные средства и особенности их регулирования

https://doi.org/10.14412/2074-2711-2016-3-82-87

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Аннотация

В статье обсуждаются факторы, влияющие на эффективность и безопасность воспроизведенных препаратов, включая обычные генерики, биоаналоги и воспроизведенные копии небиологических лекарственных средств сложного химического строения. Подчеркивается значение адекватных регуляторных требований для обеспечения сравнимой терапевтической эффективности и сопоставимого соотношения «затраты/эффективность» для воспроизведенных препаратов по сравнению с оригинальными.

Об авторах

Е. А. Ушкалова
Кафедра общей и клинической фармакологии ФГБОУ ВО «Российский университет дружбы народов», Москва, Россия 117198, Москва, ул. Миклухо-Маклая, 6
Россия


С. К. Зырянов
Кафедра общей и клинической фармакологии ФГБОУ ВО «Российский университет дружбы народов», Москва, Россия 117198, Москва, ул. Миклухо-Маклая, 6
Россия


А. В. Ушкалова
Клиника «Душевное здоровье», Московская область, Россия 143590, Московская область, Истринский район, деревня Ленино, ул. Живописная, 120
Россия


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Для цитирования:


Ушкалова Е.А., Зырянов С.К., Ушкалова А.В. Воспроизведенные лекарственные средства и особенности их регулирования. Неврология, нейропсихиатрия, психосоматика. 2016;8(3):82-87. https://doi.org/10.14412/2074-2711-2016-3-82-87

For citation:


Ushkalova E.A., Zyryanov S.K., Ushkalova A.V. Generics and the specific features of their regulation. Neurology, Neuropsychiatry, Psychosomatics. 2016;8(3):82-87. (In Russ.) https://doi.org/10.14412/2074-2711-2016-3-82-87

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ISSN 2074-2711 (Print)
ISSN 2310-1342 (Online)