METHODOLOGICAL APPROACHES TO EXPERT EVALUATION OF PRECLINICAL AND CLINICAL TRIALS OF HUMAN IMMUNOGLOBULIN PRODUCTS

METHODOLOGICAL APPROACHES TO EXPERT EVALUATION OF PRECLINICAL AND CLINICAL TRIALS OF HUMAN IMMUNOGLOBULIN PRODUCTS

The article considers the experience of Russian and leading foreign regulatory agencies in organisation and conduction of preclinical and clinical trials of human immunoglobulin products. The authors suggest a classification of human immunoglobulins and provide updated information on authorization o...

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Bibliographic Details
Main Authors: V. B. Ivanov, V. D. Mosyagin, E. Yu. Kudasheva, Yu. V. Olefir, V. A. Merkulov, I. V. Borisevitch, V. P. Bondarev
Format: Article
Language:Russian
Published: SPb RAACI 2017-10-01
Series:Medicinskaâ Immunologiâ
Subjects:
human immunoglobulin products
preclinical trials
clinical trials
expert evaluation
methodological approaches
evaluation criteria
authorization
expert body’s requirements
Online Access:https://www.mimmun.ru/mimmun/article/view/1363

Internet

https://www.mimmun.ru/mimmun/article/view/1363

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