Сравнительная характеристика препаратов ванкомицина, зарегистрированных в РФ
Abstract
Целью настоящей работы явилась экспертная оценка эквивалентности требований к качеству препаратов ванкомицина (по состоянию на 15 сентября 2008 г.):
- Эдицин (Lek д.д., Словения — в настоящий момент — подразделение ЗАО «Сандоз»);
- Ванкорус (ОАО «Акционерное Курганское общество медицинских препаратов и изделий «Синтез», Россия);
- Ванкомицин-Тева (Тева фармацевтические предприятия Лтд., Израиль);
- Веро-ванкомицин (ООО «ЛЭНС-Фарм», Россия);
- Ванкоцин (Эли Лили Восток С.А., Швейцария — оригинальный препарат).
Необходимостью в проведении этого исследования являлось то, что при регистрации лекарственных препаратов каждый производитель дженерика регистрирует собственный вариант требуемой документации. В результате требования к качеству различных дженериков могут быть различны. Анализ нормативной документации (НД) проводился с использованием инструкций к препаратам и паспортов качества.
Программа исследования проводилась по следующему алгоритму:
- Анализ литературных источников по безопасности применения ванкомицина;
- Экспертиза показателей соответствия НД;
- Анализ инструкций по применению препаратов и паспортов качества.
Материалы и методы
В ходе исследования был проведен расширенный информационный поиск в биомедицинских базах данных Embase, RxList, MedWatch, Cochrane Collaboration, списках литературы оригинальных обзоров и статей; производился анализ реферативных данных; отбирались публикации, содержащие информацию о клинических исследованиях, обзоры о применении ванкомицина и его побочных эффектах.
Анализ нормативной документации проводился по базе данных Воронежского ЦККиСЛС, с использованием инструкций к препаратам и паспортов качества.
About the Authors
Д. БелоусовООО "Центр фармакоэкономических исследований", г. Москва
Russian Federation
Ю. Белоусов
Russian Federation
О. Селютин
Russian Federation
О. Филиппова
Russian Federation
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