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