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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Autores principales:	V. B. Ivanov, V. D. Mosyagin, E. Yu. Kudasheva, Yu. V. Olefir, V. A. Merkulov, I. V. Borisevitch, V. P. Bondarev
Formato:	article
Lenguaje:	RU
Publicado:	SPb RAACI 2017
Materias:	human immunoglobulin products preclinical trials clinical trials expert evaluation methodological approaches evaluation criteria authorization expert body’s requirements Immunologic diseases. Allergy RC581-607
Acceso en línea:	https://doaj.org/article/0b020f913f10498590256ea1bff73123
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spelling	oai:doaj.org-article:0b020f913f10498590256ea1bff731232021-11-18T08:03:46ZMETHODOLOGICAL APPROACHES TO EXPERT EVALUATION OF PRECLINICAL AND CLINICAL TRIALS OF HUMAN IMMUNOGLOBULIN PRODUCTS1563-06252313-741X10.15789/1563-0625-2017-5-615-628https://doaj.org/article/0b020f913f10498590256ea1bff731232017-10-01T00:00:00Zhttps://www.mimmun.ru/mimmun/article/view/1363https://doaj.org/toc/1563-0625https://doaj.org/toc/2313-741XThe 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 of these products in Russia. The article summarizes methodological approaches, basic scientific principles and criteria relating to expert evaluation of preclinical and clinical trials of blood products. The authors further define the expert body’s requirements for data on preclinical and clinical trials of human normal immuniglobulins and human specific immunoglobulins for the prevention and/or treatment of infectious and non-infectious diseases which are submitted as part of applications for marketing authorization or marketing authorization variation. The article suggests programs of preclinical and clinical trials for human normal immunoglobulins and human specific immunoglobulins for the prevention and/or treatment of infectious and non-infectious diseases that are aligned with the Russian legislation and Eurasian Economic Union’s regulations on medicines circulation, and have been elaborated with respect to the guidelines of the European Medicines Agency.V. B. IvanovV. D. MosyaginE. Yu. KudashevaYu. V. OlefirV. A. MerkulovI. V. BorisevitchV. P. BondarevSPb RAACIarticlehuman immunoglobulin productspreclinical trialsclinical trialsexpert evaluationmethodological approachesevaluation criteriaauthorizationexpert body’s requirementsImmunologic diseases. AllergyRC581-607RUMedicinskaâ Immunologiâ, Vol 19, Iss 5, Pp 615-628 (2017)
institution	DOAJ
collection	DOAJ
language	RU
topic	human immunoglobulin products preclinical trials clinical trials expert evaluation methodological approaches evaluation criteria authorization expert body’s requirements Immunologic diseases. Allergy RC581-607
spellingShingle	human immunoglobulin products preclinical trials clinical trials expert evaluation methodological approaches evaluation criteria authorization expert body’s requirements Immunologic diseases. Allergy RC581-607 V. B. Ivanov V. D. Mosyagin E. Yu. Kudasheva Yu. V. Olefir V. A. Merkulov I. V. Borisevitch V. P. Bondarev METHODOLOGICAL APPROACHES TO EXPERT EVALUATION OF PRECLINICAL AND CLINICAL TRIALS OF HUMAN IMMUNOGLOBULIN PRODUCTS
description	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 of these products in Russia. The article summarizes methodological approaches, basic scientific principles and criteria relating to expert evaluation of preclinical and clinical trials of blood products. The authors further define the expert body’s requirements for data on preclinical and clinical trials of human normal immuniglobulins and human specific immunoglobulins for the prevention and/or treatment of infectious and non-infectious diseases which are submitted as part of applications for marketing authorization or marketing authorization variation. The article suggests programs of preclinical and clinical trials for human normal immunoglobulins and human specific immunoglobulins for the prevention and/or treatment of infectious and non-infectious diseases that are aligned with the Russian legislation and Eurasian Economic Union’s regulations on medicines circulation, and have been elaborated with respect to the guidelines of the European Medicines Agency.
format	article
author	V. B. Ivanov V. D. Mosyagin E. Yu. Kudasheva Yu. V. Olefir V. A. Merkulov I. V. Borisevitch V. P. Bondarev
author_facet	V. B. Ivanov V. D. Mosyagin E. Yu. Kudasheva Yu. V. Olefir V. A. Merkulov I. V. Borisevitch V. P. Bondarev
author_sort	V. B. Ivanov
title	METHODOLOGICAL APPROACHES TO EXPERT EVALUATION OF PRECLINICAL AND CLINICAL TRIALS OF HUMAN IMMUNOGLOBULIN PRODUCTS
title_short	METHODOLOGICAL APPROACHES TO EXPERT EVALUATION OF PRECLINICAL AND CLINICAL TRIALS OF HUMAN IMMUNOGLOBULIN PRODUCTS
title_full	METHODOLOGICAL APPROACHES TO EXPERT EVALUATION OF PRECLINICAL AND CLINICAL TRIALS OF HUMAN IMMUNOGLOBULIN PRODUCTS
title_fullStr	METHODOLOGICAL APPROACHES TO EXPERT EVALUATION OF PRECLINICAL AND CLINICAL TRIALS OF HUMAN IMMUNOGLOBULIN PRODUCTS
title_full_unstemmed	METHODOLOGICAL APPROACHES TO EXPERT EVALUATION OF PRECLINICAL AND CLINICAL TRIALS OF HUMAN IMMUNOGLOBULIN PRODUCTS
title_sort	methodological approaches to expert evaluation of preclinical and clinical trials of human immunoglobulin products
publisher	SPb RAACI
publishDate	2017
url	https://doaj.org/article/0b020f913f10498590256ea1bff73123
work_keys_str_mv	AT vbivanov methodologicalapproachestoexpertevaluationofpreclinicalandclinicaltrialsofhumanimmunoglobulinproducts AT vdmosyagin methodologicalapproachestoexpertevaluationofpreclinicalandclinicaltrialsofhumanimmunoglobulinproducts AT eyukudasheva methodologicalapproachestoexpertevaluationofpreclinicalandclinicaltrialsofhumanimmunoglobulinproducts AT yuvolefir methodologicalapproachestoexpertevaluationofpreclinicalandclinicaltrialsofhumanimmunoglobulinproducts AT vamerkulov methodologicalapproachestoexpertevaluationofpreclinicalandclinicaltrialsofhumanimmunoglobulinproducts AT ivborisevitch methodologicalapproachestoexpertevaluationofpreclinicalandclinicaltrialsofhumanimmunoglobulinproducts AT vpbondarev methodologicalapproachestoexpertevaluationofpreclinicalandclinicaltrialsofhumanimmunoglobulinproducts
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METHODOLOGICAL APPROACHES TO EXPERT EVALUATION OF PRECLINICAL AND CLINICAL TRIALS OF HUMAN IMMUNOGLOBULIN PRODUCTS

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