Катрен Стиль
В ЕАЭС утвердили руководство по подбору оптимальной дозировки препаратов
Коллегия Евразийской экономической комиссии приняла рекомендации, по которым производители должны выбирать оптимальную дозировку своих ЛС для обращения на территории ЕАЭС. Документ опубликован 15 марта на сайте Евразийской комиссии.
Руководство касается выбора режима дозирования при проведении клинических исследований, которые должны проводить производители перед регистрацией препаратов. В тексте перечислены различные методы подборки оптимальной дозировки на основе концепции «доза — эффект», такие как плацебо-контролируемые исследования, ретроспективные исследования и исследования в параллельных группах. Кроме этого, в Руководстве содержатся общие методические указания по дизайну проведения (комбинации требований к сбору и анализу данных) клинических исследований.
В конце документа отмечается, что точные данные о зависимости «доза — эффект» (т. е. оптимальный подбор дозировки ЛС) могут быть предоставлены после регистрации препарата. Но только в случае, если лекарственный препарат обладает высокой терапевтической эффективностью и нуждается в срочном внедрении в клиническую практику или если регистрируемый препарат обладает очень низкой токсичностью.
В начале года Евразийской экономической комиссией было принято Руководство по выбору торговых наименований для препаратов, которые будут находиться в обращении на общем лекарственном рынке ЕАЭС.
20 марта 2019
Фото: depositphotos.com
Выпуск: №182, март 20191462 просмотров
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