Certification of a pharmacopoeial reference standard for potency testing of recombinant interferon α-2b
SCIENTIFIC RELEVANCE. Potency testing of recombinant interferons requires a reference standard. The availability of International Standards (ISs) that are commonly used to assess the quality of recombinant interferons is currently limited. Therefore, the quality of interferons should be assessed usi...
Saved in:
| Main Authors: | L. A. Gaiderova, Yu. N. Lebedeva, T. N. Lobanova, E. K. Lipatova, R. A. Volkova, O. V. Fadeikina |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2024-03-01
|
| Series: | Биопрепараты: Профилактика, диагностика, лечение |
| Subjects: | |
| Online Access: | https://www.biopreparations.ru/jour/article/view/550 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
Similar Items
-
Human anti-D immunoglobulin preparations: potency standardisation milestones
by: N. S. Vildanova, et al.
Published: (2022-10-01) -
Requirements for the information on reference standards submitted in the dossier for biologicals
by: R. A. Volkova, et al.
Published: (2024-03-01) -
Potency evaluation of erythropoietin products: current status
by: L. A. Gaiderova, et al.
Published: (2024-12-01) -
Recommendations on the certification of reference standards for structure identification of recombinant therapeutic proteins
by: O. B. Ustinnikova, et al.
Published: (2022-07-01) -
The safety, tolerability, pharmacokinetics, and pharmacodynamics of nebulized pegylated interferon α-2b in healthy adults: a randomized phase 1 trial
by: Wenqi Huang, et al.
Published: (2025-05-01)