Clinical trials for cellular therapy products: conclusions reached by foreign regulatory bodies
Currently, the problem of adopting viable human cell-based drugs – biomedical cell products (BCPs) – in medical practice in the Russian Federation includes, among others, lack of experience in clinical trials for such drugs and insufficient expert assessment under the national state registration pro...
Main Authors: | E. V. Melnikova, O. V. Merkulova, V. A. Merkulov |
---|---|
Format: | Article |
Language: | Russian |
Published: |
Federal Research Center of Transplantology and Artificial Organs named after V.I.Shumakov
2020-07-01
|
Series: | Vestnik Transplantologii i Iskusstvennyh Organov |
Subjects: | |
Online Access: | https://journal.transpl.ru/vtio/article/view/1195 |
Similar Items
-
Biomedical Cell Products or High-Tech Drugs?
by: V. A. Merkulov, et al.
Published: (2019-06-01) -
Methodological aspects of the development of product files for biomedical cell products
by: E. V. Melnikova, et al.
Published: (2021-07-01) -
International Approaches to Regulation of Medicinal Products Containing Viable Human Cells
by: E. V. Melnikova, et al.
Published: (2018-09-01) -
Treatment of Genetic Diseases: Current Trends in the Development of Biomedical Cell Products
by: O. A. Rachinskaya, et al.
Published: (2019-12-01) -
Current Trends in the Use of Cell Therapy in Regenerative Medicine
by: A. A. Chaplenko, et al.
Published: (2020-06-01)