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Comparison of pharmacopeial statistical methods applied in microbiological assay for antibiotics potency determination using parallel lines and three-dose level BJPS
Leonel,Miriam de Fátima Vianna; Soares,Cristina Duarte Vianna; Siqueira,Arminda Lucia.
Pharmaceutical equivalence studies, useful for checking the interchangeability of generic medicines and their respective innovator medicines, have been carried out in Brazil since 1999, as a consequence of the establishment of the generic medicine policy. For medicines containing antibiotics, microbiological assays are often the most appropriate method. However, the statistical methods applied in these assays are not widely known due to the difficult access to official codes and/or little knowledge of the statistical tools of analysis. Thus, the aim of this work was to compare the statistical methods for determining the potency of antibiotics through the cylinder-plate method using parallel lines and a three-dose level model, as described in the Brazilian...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Antibiotics/potency; Parallel lines model; Pharmacopeial statistical methods.
Ano: 2012 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502012000300024
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