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Analytical validation of LAL kinetic assay for detection and quantification of endotoxins in measles's vaccine diluents BABT
Guimarães,Rosane Cuber; Leal,Alaide Aline Xavier.
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...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Bioanalytical method; Endotoxin; Validation.
Ano: 2006 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-89132006000200010
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