Standardization of Immunobiological Assay for Determines Identity of Junin virus Vaccine, Candid#1
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 qualied to ensure its proper use. The aim of this study was to estimate the expanded uncertainty (U) through valid...
| Main Authors: | , , , |
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| Format: | info:ar-repo/semantics/artículo |
| Language: | Inglés |
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2019
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| Subjects: | |
| Online Access: | 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 |
| _version_ | 1855035459037560832 |
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| author | Chale, Julieta Maiza, Andrea S. Gamboa, Graciela S. Riera, Laura M. |
| author_browse | Chale, Julieta Gamboa, Graciela S. Maiza, Andrea S. Riera, Laura M. |
| author_facet | Chale, Julieta Maiza, Andrea S. Gamboa, Graciela S. Riera, Laura M. |
| author_sort | Chale, Julieta |
| collection | INTA Digital |
| 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 qualied 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 specication 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 qualication that must have an IRS to be used in quality control testing of the vaccine Candid# 1. |
| format | info:ar-repo/semantics/artículo |
| id | INTA5217 |
| institution | Instituto Nacional de Tecnología Agropecuaria (INTA -Argentina) |
| language | Inglés |
| publishDate | 2019 |
| publishDateRange | 2019 |
| publishDateSort | 2019 |
| record_format | dspace |
| spelling | INTA52172019-05-28T14:53:51Z Standardization of Immunobiological Assay for Determines Identity of Junin virus Vaccine, Candid#1 Chale, Julieta Maiza, Andrea S. Gamboa, Graciela S. Riera, Laura M. Vacuna Suero Inmune Incertidumbre Virus Vaccines Immune Serum Statistical Uncertainty Viruses Vacuna Candid#1 Virus Junín Fiebre Hemorrágica Argentina 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 qualied 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 specication 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 qualication 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 2019-05-28T14:36:56Z 2019-05-28T14:36:56Z 2017-04 info:ar-repo/semantics/artículo info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion 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 eng 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) application/pdf Research & Reviews: Journal of Pharmaceutical Analysis 6 (1) : 10-14 (April 2017) |
| spellingShingle | Vacuna Suero Inmune Incertidumbre Virus Vaccines Immune Serum Statistical Uncertainty Viruses Vacuna Candid#1 Virus Junín Fiebre Hemorrágica Argentina Chale, Julieta Maiza, Andrea S. Gamboa, Graciela S. Riera, Laura M. 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 |
| 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_short | 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 |
| topic | Vacuna Suero Inmune Incertidumbre Virus Vaccines Immune Serum Statistical Uncertainty Viruses Vacuna Candid#1 Virus Junín Fiebre Hemorrágica Argentina |
| 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 |
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