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Разработка и регистрация лекарственных средств

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АНАЛИЗ МЕЖДУНАРОДНЫХ ТРЕБОВАНИЙ К КОМПЛЕКСНОМУ ПРОЕКТИРОВАНИЮ КЛИНИЧЕСКИХ ИССЛЕДОВАНИЙ ЛЕКАРСТВЕННЫХ СРЕДСТВ

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Аннотация

При проведении анализа международных требований к комплексному проектированию клинических исследований лекарственных средств было установлено, что глобальным документом являются стандарты ICH; на национальном уровне в Российской Федерации данным стандартом является ГОСТ Р 52379 -2005 «Над лежащая клиническая практика», текст которого идентичен руководству по над лежащей клинической практике (Consolidated Guideline for Good Clinical Practice). Детализированные международные требования, регламентирующие различные аспекты проведения клинических исследований, разрабатываются глобальными регуляторами: FDA и EMA. В настоящее время в Российской Федерации отсутствуют локальные нормативные документы, регламентирующие проектирование клинических исследований лекарственных средств, в этой связи с большой долей вероятности можно говорить о необходимости разработки национальных документов, регламентирующих различные аспекты планирования клинических исследований, и синхронизации данной нормативной базы с международными документами с целью обеспечения эффективного выхода отечественных лекарственных средств на зарубежные рынки.

Об авторах

О. С. Кобякова
ГБОУ ВПО «Сибирский государственный медицинский университет»
Россия


Е. С. Куликов
ГБОУ ВПО «Сибирский государственный медицинский университет»
Россия


И. А. Деев
ГБОУ ВПО «Сибирский государственный медицинский университет»
Россия


А. А. Дмитриев
ГБОУ ВПО «Сибирский государственный медицинский университет»
Россия


Н. А. Табакаев
ГБОУ ВПО «Сибирский государственный медицинский университет»
Россия


И. Д. Пименов
ГБОУ ВПО «Сибирский государственный медицинский университет»
Россия


Д. С. Тюфилин
ГБОУ ВПО «Сибирский государственный медицинский университет»
Россия


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Для цитирования:


Кобякова О.С., Куликов Е.С., Деев И.А., Дмитриев А.А., Табакаев Н.А., Пименов И.Д., Тюфилин Д.С. АНАЛИЗ МЕЖДУНАРОДНЫХ ТРЕБОВАНИЙ К КОМПЛЕКСНОМУ ПРОЕКТИРОВАНИЮ КЛИНИЧЕСКИХ ИССЛЕДОВАНИЙ ЛЕКАРСТВЕННЫХ СРЕДСТВ. Разработка и регистрация лекарственных средств. 2016;(2):172-178.

For citation:


Kobyakova O.S., Kulikov E.S., Deev I.A., Dmitriev A.A., Tabakaev N.A., Pimenov I.D., Tyufilin D.S. ANALYSIS OF INTERNATIONAL REQUIREMENTS FOR DESIGNING OF CLINICAL TRIALS. Drug development & registration. 2016;(2):172-178. (In Russ.)

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