Standardization of Immunobiological Assay for Determines Identity of Junin virus Vaccine, Candid#1

Autores
Chale, Julieta; Maiza, Andrea S.; Gamboa, Graciela S.; Riera, Laura M.
Año de publicación
2017
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
The quality control tests of the Candid#1 vaccine required for internal release needs the use of rabbit immune serum (RIS). It is a biological reagent produced in INEVH and it must be qualied to ensure its proper use. The aim of this study was to estimate the expanded uncertainty (U) through validation studies of identity test in which the titles of IRS are determined, and thus establish its specication for use in control tests where the title of it is critical. Validation studies made possible calculate the U established by statistical analysis of the values obtained experimentally in intermediate precision, resulting=0.30. Determination of the U of the methodology established that 500 is the minimum qualication that must have an IRS to be used in quality control testing of the vaccine Candid# 1.
EEA Pergamino
Fil: Chale, Julieta. Instituto Nacional de Tecnología Agropecuaria (INTA). Estación Experimental Agropecuaria Pergamino. Sección Aves; Argentina
Fil: Maiza, Andrea. Instituto Nacional de Enfermedades Virales Humanas "Dr. Julio I. Maiztegui"; Argentina
Fil: Gamboa, Graciela. Instituto Nacional de Enfermedades Virales Humanas "Dr. Julio I. Maiztegui"; Argentina
Fil: Riera, Laura. Instituto Nacional de Enfermedades Virales Humanas "Dr. Julio I. Maiztegui"; Argentina
Fuente
Research & Reviews: Journal of Pharmaceutical Analysis 6 (1) : 10-14 (April 2017)
Materia
Vacuna
Suero Inmune
Incertidumbre
Virus
Vaccines
Immune Serum
Statistical Uncertainty
Viruses
Vacuna Candid#1
Virus Junín
Fiebre Hemorrágica Argentina
Nivel de accesibilidad
acceso abierto
Condiciones de uso
http://creativecommons.org/licenses/by-nc-sa/4.0/
Repositorio
INTA Digital (INTA)
Institución
Instituto Nacional de Tecnología Agropecuaria
OAI Identificador
oai:localhost:20.500.12123/5217
Acceder
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oai_identifier_str oai:localhost:20.500.12123/5217
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network_name_str INTA Digital (INTA)
spelling Standardization of Immunobiological Assay for Determines Identity of Junin virus Vaccine, Candid#1Chale, JulietaMaiza, Andrea S.Gamboa, Graciela S.Riera, Laura M.VacunaSuero InmuneIncertidumbreVirusVaccinesImmune SerumStatistical UncertaintyVirusesVacuna Candid#1Virus JunínFiebre Hemorrágica ArgentinaThe quality control tests of the Candid#1 vaccine required for internal release needs the use of rabbit immune serum (RIS). It is a biological reagent produced in INEVH and it must be qualied to ensure its proper use. The aim of this study was to estimate the expanded uncertainty (U) through validation studies of identity test in which the titles of IRS are determined, and thus establish its specication for use in control tests where the title of it is critical. Validation studies made possible calculate the U established by statistical analysis of the values obtained experimentally in intermediate precision, resulting=0.30. Determination of the U of the methodology established that 500 is the minimum qualication that must have an IRS to be used in quality control testing of the vaccine Candid# 1.EEA PergaminoFil: Chale, Julieta. Instituto Nacional de Tecnología Agropecuaria (INTA). Estación Experimental Agropecuaria Pergamino. Sección Aves; ArgentinaFil: Maiza, Andrea. Instituto Nacional de Enfermedades Virales Humanas "Dr. Julio I. Maiztegui"; ArgentinaFil: Gamboa, Graciela. Instituto Nacional de Enfermedades Virales Humanas "Dr. Julio I. Maiztegui"; ArgentinaFil: Riera, Laura. Instituto Nacional de Enfermedades Virales Humanas "Dr. Julio I. Maiztegui"; Argentina2019-05-28T14:36:56Z2019-05-28T14:36:56Z2017-04info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfhttp://www.rroij.com/open-access/pdfdownload.php?download=standardization-of-immunobiological-assay-for-determines-identityof-junin-virus-vaccine-candid-1-.pdf&aid=86107http://hdl.handle.net/20.500.12123/52172320-0812 (digital)2347-2340Research & Reviews: Journal of Pharmaceutical Analysis 6 (1) : 10-14 (April 2017)reponame:INTA Digital (INTA)instname:Instituto Nacional de Tecnología Agropecuariaenginfo:eu-repo/semantics/openAccesshttp://creativecommons.org/licenses/by-nc-sa/4.0/Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0)2025-11-13T08:46:17Zoai:localhost:20.500.12123/5217instacron:INTAInstitucionalhttp://repositorio.inta.gob.ar/Organismo científico-tecnológicoNo correspondehttp://repositorio.inta.gob.ar/oai/requesttripaldi.nicolas@inta.gob.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:l2025-11-13 08:46:17.586INTA Digital (INTA) - Instituto Nacional de Tecnología Agropecuariafalse
dc.title.none.fl_str_mv Standardization of Immunobiological Assay for Determines Identity of Junin virus Vaccine, Candid#1
title Standardization of Immunobiological Assay for Determines Identity of Junin virus Vaccine, Candid#1
spellingShingle Standardization of Immunobiological Assay for Determines Identity of Junin virus Vaccine, Candid#1
Chale, Julieta
Vacuna
Suero Inmune
Incertidumbre
Virus
Vaccines
Immune Serum
Statistical Uncertainty
Viruses
Vacuna Candid#1
Virus Junín
Fiebre Hemorrágica Argentina
title_short Standardization of Immunobiological Assay for Determines Identity of Junin virus Vaccine, Candid#1
title_full Standardization of Immunobiological Assay for Determines Identity of Junin virus Vaccine, Candid#1
title_fullStr Standardization of Immunobiological Assay for Determines Identity of Junin virus Vaccine, Candid#1
title_full_unstemmed Standardization of Immunobiological Assay for Determines Identity of Junin virus Vaccine, Candid#1
title_sort Standardization of Immunobiological Assay for Determines Identity of Junin virus Vaccine, Candid#1
dc.creator.none.fl_str_mv Chale, Julieta
Maiza, Andrea S.
Gamboa, Graciela S.
Riera, Laura M.
author Chale, Julieta
author_facet Chale, Julieta
Maiza, Andrea S.
Gamboa, Graciela S.
Riera, Laura M.
author_role author
author2 Maiza, Andrea S.
Gamboa, Graciela S.
Riera, Laura M.
author2_role author
author
author
dc.subject.none.fl_str_mv Vacuna
Suero Inmune
Incertidumbre
Virus
Vaccines
Immune Serum
Statistical Uncertainty
Viruses
Vacuna Candid#1
Virus Junín
Fiebre Hemorrágica Argentina
topic Vacuna
Suero Inmune
Incertidumbre
Virus
Vaccines
Immune Serum
Statistical Uncertainty
Viruses
Vacuna Candid#1
Virus Junín
Fiebre Hemorrágica Argentina
dc.description.none.fl_txt_mv The quality control tests of the Candid#1 vaccine required for internal release needs the use of rabbit immune serum (RIS). It is a biological reagent produced in INEVH and it must be qualied to ensure its proper use. The aim of this study was to estimate the expanded uncertainty (U) through validation studies of identity test in which the titles of IRS are determined, and thus establish its specication for use in control tests where the title of it is critical. Validation studies made possible calculate the U established by statistical analysis of the values obtained experimentally in intermediate precision, resulting=0.30. Determination of the U of the methodology established that 500 is the minimum qualication that must have an IRS to be used in quality control testing of the vaccine Candid# 1.
EEA Pergamino
Fil: Chale, Julieta. Instituto Nacional de Tecnología Agropecuaria (INTA). Estación Experimental Agropecuaria Pergamino. Sección Aves; Argentina
Fil: Maiza, Andrea. Instituto Nacional de Enfermedades Virales Humanas "Dr. Julio I. Maiztegui"; Argentina
Fil: Gamboa, Graciela. Instituto Nacional de Enfermedades Virales Humanas "Dr. Julio I. Maiztegui"; Argentina
Fil: Riera, Laura. Instituto Nacional de Enfermedades Virales Humanas "Dr. Julio I. Maiztegui"; Argentina
description The quality control tests of the Candid#1 vaccine required for internal release needs the use of rabbit immune serum (RIS). It is a biological reagent produced in INEVH and it must be qualied to ensure its proper use. The aim of this study was to estimate the expanded uncertainty (U) through validation studies of identity test in which the titles of IRS are determined, and thus establish its specication for use in control tests where the title of it is critical. Validation studies made possible calculate the U established by statistical analysis of the values obtained experimentally in intermediate precision, resulting=0.30. Determination of the U of the methodology established that 500 is the minimum qualication that must have an IRS to be used in quality control testing of the vaccine Candid# 1.
publishDate 2017
dc.date.none.fl_str_mv 2017-04
2019-05-28T14:36:56Z
2019-05-28T14:36:56Z
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://www.rroij.com/open-access/pdfdownload.php?download=standardization-of-immunobiological-assay-for-determines-identityof-junin-virus-vaccine-candid-1-.pdf&aid=86107
http://hdl.handle.net/20.500.12123/5217
2320-0812 (digital)
2347-2340
url http://www.rroij.com/open-access/pdfdownload.php?download=standardization-of-immunobiological-assay-for-determines-identityof-junin-virus-vaccine-candid-1-.pdf&aid=86107
http://hdl.handle.net/20.500.12123/5217
identifier_str_mv 2320-0812 (digital)
2347-2340
dc.language.none.fl_str_mv eng
language eng
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
http://creativecommons.org/licenses/by-nc-sa/4.0/
Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0)
eu_rights_str_mv openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by-nc-sa/4.0/
Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0)
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv Research & Reviews: Journal of Pharmaceutical Analysis 6 (1) : 10-14 (April 2017)
reponame:INTA Digital (INTA)
instname:Instituto Nacional de Tecnología Agropecuaria
reponame_str INTA Digital (INTA)
collection INTA Digital (INTA)
instname_str Instituto Nacional de Tecnología Agropecuaria
repository.name.fl_str_mv INTA Digital (INTA) - Instituto Nacional de Tecnología Agropecuaria
repository.mail.fl_str_mv tripaldi.nicolas@inta.gob.ar
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score 12.738264

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