Development of an Approach to the Assessment of Changes to Approved Biological Products
The need to strengthen the post-approval regulation of biological products stems from their increasing role in the treatment of serious human diseases. Until recently, there were open questions on the classification of changes and supporting data necessary to confirm the comparability of a biologica...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2019-06-01
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| Series: | Биопрепараты: Профилактика, диагностика, лечение |
| Subjects: | |
| Online Access: | https://www.biopreparations.ru/jour/article/view/220 |