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: | E. V. Petraneva, I. A. Proskurina, D. V. Goryachev, E. L. Kovaleva |
---|---|
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
|
Series: | Биопрепараты: Профилактика, диагностика, лечение |
Subjects: | |
Online Access: | https://www.biopreparations.ru/jour/article/view/220 |
Similar Items
-
Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward
by: Tariro Sithole, et al.
Published: (2021-08-01) -
Product Complexity and Strategic Alliance on Drug Approval
by: Taoyong Su, et al.
Published: (2021-05-01) -
Alignment in post-approval changes (PAC) guidelines in emerging countries may increase timely access to vaccines: An illustrative assessment by manufacturers
by: Nora Dellepiane, et al.
Published: (2020-12-01) -
Analysis of the Regulatory Science Applied to a Single Portfolio of Eight Biosimilar Product Approvals by Four Key Regulatory Authorities
by: Beverly Ingram, et al.
Published: (2021-04-01) -
Disease modification in osteoarthritis; pathways to drug approval
by: Jeffrey N. Katz, et al.
Published: (2020-06-01)