Justification of Methodological Approaches to Identification Testing of Biomedical Cell Products
The manufacturer (developer) has to prepare a specification for each newly developed biomedical cell product (BCP) that has passed the stage of preclinical studies. The specification is included into the registration dossier when applying for marketing authorisation of a BCP. In accordance with the...
Main Authors: | , , , , , , |
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Format: | Article |
Language: | Russian |
Published: |
Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2019-03-01
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Series: | Биопрепараты: Профилактика, диагностика, лечение |
Subjects: | |
Online Access: | https://www.biopreparations.ru/jour/article/view/203 |