Recommendations for drafting regulatory documents on immunobiological medicines particularly the section on physicochemical quality characteristics

These recommendations present the specifics of laboratory testing and examination of regulatory documents. The recommendations include information about the basic principles of presentation of the quality assessment methods. The paper demonstrates the following: a general presentation scheme of regu...

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Bibliographic Details
Main Authors: O. B. Ustinnikova, O. B. Runova, E. V. Velichko
Format: Article
Language:Russian
Published: OOO “Vashe Tsifrovoe Izdatelstvo” 2018-02-01
Series:Ведомости Научного центра экспертизы средств медицинского применения
Subjects:
Online Access:https://www.vedomostincesmp.ru/jour/article/view/45