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1 Abbreviated New Drug Application
1) Общая лексика: Сокращенная заявка о получении разрешения на маркетинг (Cокращенная заявка относительно одобрения нового лекарственного средства (ANDA) представляет собой документ, который подается с целью получить разрешение на испо)Универсальный англо-русский словарь > Abbreviated New Drug Application
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2 Abbreviated New Drug Application
Заявка в регуляторный орган США (FDA) на получение торговой лицензии (регистрацию) на генерическую версию оригинального препарата, который уже прошел полную процедуру лицензирования (регистрации) и разрешен для продажи. Поскольку для оригинального препарата полностью доказано соответствие установленным стандартам безопасности и эффективности, то для лицензирования генерической версии не требуется предоставления результатов некоторых испытаний (фармакологических, токсикологических, клинических), но при этом необходимо доказать, что препарат по существу аналогичен оригинальному (например, предоставить доказательства биоэквивалентности).English-Russian glossary of clinical practice > Abbreviated New Drug Application
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3 ANDA
Физиология: Abbreviated New Drug Application -
4 Anda
Физиология: Abbreviated New Drug Application
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