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dc.date.accessioned | 2009-10-01T13:02:22Z | |
dc.date.available | 2009-10-01T03:00:00Z | |
dc.date.issued | 2009 | es |
dc.identifier.uri | http://sedici.unlp.edu.ar/handle/10915/7815 | |
dc.description.abstract | O presente estudo foi realizado visando a validação do PTSTM (Portable Test System) como metodologia padrão para ensaio de endotoxina em radiofármacos (18-FDG). A análise foi guiada pela Resolução Anvisa RE 899/2003. Os resultados demonstram adequação da técnica à rotina de radiofármacos, mesmo que no quesito exatidão os resultados tenham sido desfavoráveis a sua utilização. Contudo, avaliando-se o benefício de seu uso, a técnica mostrou-se uma alternativa ao teste farmacopéico atual. | es |
dc.description.abstract | The endotoxin test is an important parameter for medicines, specially the radiopharmaceuticals one, since the presence of endotoxin can be dangerous. Nowadays, two techniques are been used for radiopharmaceuticals endotoxin test. First, the traditional one, the BET (Bacterial Endotoxin Test) described in United States Pharmacopoeia. Second the PTSTM (Portable Test System) approved by the FDA. However, since the PTSTM is not a pharmacopeial test he must be validated before been used for routine. The present study was conducted to validated the PTSTM as standard methodology for endotoxin assay. The results, except accuracy, were good. Although the results of accuracy were not good this technique seems to be a important alternative test, especially for radiopharmaceuticals. | en |
dc.format.extent | 633-637 | es |
dc.language | pt | es |
dc.subject | endotoxina; ensayo microbiológico; Endosafe®; LAL | es |
dc.subject | Radiofármacos | es |
dc.subject | endotoxin; Endosafe®; LAL; microbiological assay | en |
dc.title | Validação do PTSTM (Portable Test System) para ensaio de endotoxina em radiofármacos (18-FDG) | es |
dc.title.alternative | Validation of PTS for radiopharmaceuticals endotoxin test | en |
dc.type | Articulo | es |
sedici.identifier.uri | http://www.latamjpharm.org/trabajos/28/4/LAJOP_28_4_2_12_1G02837980.pdf | es |
sedici.creator.person | Santos Oliveira, Ralph | es |
sedici.subject.materias | Farmacia | es |
sedici.description.fulltext | true | es |
mods.originInfo.place | Colegio de Farmacéuticos de la Provincia de Buenos Aires | es |
sedici.subtype | Comunicacion | es |
sedici2003.identifier | ARG-FARM-ART-0000001301 | es |
sedici.relation.journalTitle | Latin American Journal of Pharmacy | es |
sedici.relation.journalVolumeAndIssue | vol. 28, no. 4 | es |