Evaluation of the Activity of Drugs Containing Human Cell Lines: Promising Approaches and Requirements of Regulatory Bodies

This article analyzes the latest requirements of the US and European regulatory authorities for the assessment of the activity of preparations containing human cell lines (biomedical cell product analogues); it gives a review of methods and approaches to the assessment of activity used by manufactur...

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Bibliographic Details
Main Authors: A. A. Chaplenko, E. V. Melnikova, O. A. Rachinskaya, Yu. V. Olefir
Format: Article
Language:Russian
Published: LLC "Publishing House OKI" 2020-05-01
Series:Антибиотики и Химиотерапия
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Online Access:https://www.antibiotics-chemotherapy.ru/jour/article/view/192
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