Standard instructions for medical use of interchangeable drugs: analysis of modern regulatory documents

Standard instructions for medical use of interchangeable drugs: analysis of modern regulatory documents

The article presents a review of modern regulatory and legal framework and draft regulatory documents on circulation of interchangeable drugs with regard to standard instructions for medical use. The analysis included more than 70 documents. There are two slightly different notions in this field: a...

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Bibliographic Details
Main Authors: M. V. Zhuravleva, V. G. Kukes, Yu. V. Olefir, B. K. Romanov, A. B. Prokofiev, S. Yu. Serebrova, G. I. Gorodetskaya, V. V. Arkhipov, N. B. Lazareva
Format: Article
Language:Russian
Published: OOO “Vashe Tsifrovoe Izdatelstvo” 2018-02-01
Series:Ведомости Научного центра экспертизы средств медицинского применения
Subjects:
типовая инструкция по медицинскому применению
взаимозаменяемые лекарственные препараты
нормативно-правовые документы
вспомогательные вещества
доклинические исследования
клинические исследования
обращение лекарственных средств
standard instruction for medical use
interchangeable drugs
regulatory and legal framework
excipients
preclinical studies
clinical trials
circulation of medicines
Online Access:https://www.vedomostincesmp.ru/jour/article/view/99

Internet

https://www.vedomostincesmp.ru/jour/article/view/99

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