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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


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