Катрен Стиль
В США отказались от доклинических исследований ЛС на животных
Управление по санитарному надзору за качеством пищевых продуктов и медикаментов США (FDA) больше не будет требовать у производителей лекарственных препаратов результаты исследований на животных при выдаче разрешения на проведение клинических исследований. Соответствующий акт был одобрен Сенатом США. Об этом пишет журнал Science.
Вместо опытов на животных производители могут проводить испытания на органоидах — искусственно созданных из стволовых клеток тканях, имитирующих поведение различных человеческих органов. Кроме этого, исследования токсичности препарата можно проводить при помощи компьютерного моделирования или специальных моделей органов, созданных из полимерных материалов.
Необходимость предварительного тестирования ЛС на животных ранее была закреплена законом и регулярно подвергалась критике со стороны фармкомпаний. Так, согласно последнему исследованию почти девять из десяти препаратов, прошедших испытания на животных, провалили первую фазу клинических исследований, так как оказались небезопасными для человеческого организма. Таким образом, эти исследования не только требуют затрат со стороны производителей, но и зачастую оказываются неэффективными.
В России, согласно Правилам надлежащей лабораторной практики и Правилам надлежащей лабораторной практики Евразийского экономического союза в сфере обращения лекарственных средств, проведение доклинических исследований ЛС именно на животных не является обязательным.
16 января 2023
Фото: © Farinosa / Фотобанк Фотодженика
Выпуск: №229, январь 2023470 просмотров
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