Data/hora: 04/06/2024 17:05:45

Provedor de dados: | Brazilian Archives of Biology and Technology
País: | Brazil
Título: | Analytical validation of LAL kinetic assay for detection and quantification of endotoxins in measles's vaccine diluents
Autores: | Guimarães,Rosane Cuber; Leal,Alaide Aline Xavier.
Data: | 2006-01-01
Ano: | 2006
Palavras-chave: | Bioanalytical method; Endotoxin; Validation.
Resumo: | Method validation is the process used to confirm that the analytical procedures employed for a specific test is able to produce reliable and replicable results. An analytical method should be conducted in order to demonstrate that it is suitable for its intended use [1]. The aim of this present work is to demonstrate and evaluate the suitability of method validation. The analytical validation discussed herein was conducted by prescribed protocol, using 3 different batches of measles's vaccine diluents. All of the stipulated validation parameters: linearity, repeatability, reproducibility (intermediate precision) and accuracy were met. Additionally, this study demonstrated the method's capability for the determining endotoxin levels in measles's vaccine diluents and its further use in apirogenic water samples.
Tipo: | Info:eu-repo/semantics/article
Idioma: | Inglês
Identificador: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-89132006000200010
Editor: | Instituto de Tecnologia do Paraná - Tecpar
Relação: | 10.1590/S1516-89132006000200010
Formato: | text/html
Fonte: | Brazilian Archives of Biology and Technology  v.49 n.spe 2006
Fonte: | info:eu-repo/semantics/openAccess