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...

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Bibliographic Details
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