Demonstration of Quality, Safety and Efficacy of Biological Products Subject to Changes in Their Manufacturing Process
Ensuring quality, safety and efficacy of the medicinal products placed on the market of the Russian Federation constitutes the area that requires strict regulation. When changes are made to the manufacturing process, the manufacturer generally needs to evaluate the relevant quality attributes of the...
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| Main Authors: | , , , , |
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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/510 |
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