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| 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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| Costa,André Lima de Oliveira; Enéas,Paula Cristina Rezende; Miranda,Tiago Assis; Mingoti,Sueli Aparecida; Soares,Cristina Duarte Vianna; Pianetti,Gerson Antônio. |
| Mycophenolate mofetil (MMF) and mycophenolate sodium (MPS) are an ester and a salt of mycophenolic acid. They have different kinetic in vivo characteristics due to differences in molecular structures, physicochemical properties and formulations administered. In this study, dissolution profiles of reference products were tested in different media to evaluate the effect of pH, kinetic dissolution and the best statistical model that can be used to predict the release of both drugs. The drug release was determined by using a validated ultraviolet spectrophotometry method, λ 250 nm. The method showed to be selective, linear, precise and accurate for MMF in 0.1 M HCl and MPS in sodium phosphate buffer pH 6.8. Dissolution kinetics models of zero order, first... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Mycophenolate sodium; Mycophenolate mofetil; Dissolution profiles; Weibull kinetics. |
| Ano: 2013 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000200013 |
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