Comparison of pharmacopeial statistical methods applied in microbiological assay for antibiotics potency determination using parallel lines and three-dose level
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, microb...
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doaj-6c33eb3e442d4ce0916fe43879f379e32020-11-25T00:02:13ZengUniversidade de São PauloBrazilian Journal of Pharmaceutical Sciences1984-82502175-97902012-09-0148356557610.1590/S1984-82502012000300024Comparison of pharmacopeial statistical methods applied in microbiological assay for antibiotics potency determination using parallel lines and three-dose levelMiriam de Fátima Vianna LeonelCristina Duarte Vianna SoaresArminda Lucia SiqueiraPharmaceutical 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 Pharmacopeia (4th edition, 1988), British Pharmacopoeia 2011, European Pharmacopoeia (7th edition), The International Pharmacopoeia (4th edition), and United States Pharmacopeia (34th edition). The assay is illustrated with the antibiotic ofloxacin, and details on orthogonal coefficients, normality test, homogeneity of variance test, and detection of outliers are discussed. The calculations obtained by statistical analyses from different pharmacopeias lead to the same final interpretation. In practice, with the availability of alternative pharmacopeial methods, the analyst can choose the most appropriate statistical calculation to be used.<br>Os estudos de equivalência farmacêutica, úteis na verificação da intercambialidade entre os medicamentos genéricos e respectivos medicamentos de referência, têm sido realizados no Brasil desde 1999, como consequência do estabelecimento da política de medicamentos genéricos. Para medicamentos contendo antibióticos, os ensaios microbiológicos são, muitas vezes, o método mais adequado. Entretanto, os métodos estatísticos aplicados nesses ensaios não são amplamente conhecidos devido à dificuldade de acesso aos compêndios oficiais e/ou pouca compreensão das ferramentas estatísticas de análises. Portanto, o objetivo desse trabalho foi comparar os métodos estatísticos para determinação de potência de antibióticos pelo delineamento por retas paralelas e três níveis de doses, descritos nas farmacopeias Brasileira 4. ed. (1988), Britânica 2011, Europeia 7. ed., Internacional 4. ed. e na Farmacopeia dos Estados Unidos 34. ed. (2011). O ensaio é exemplificado com o antibiótico ofloxacino e detalhes sobre coeficientes ortogonais, teste de normalidade, teste de homogeneidade de variância e detecção de outliers são discutidos. Os cálculos obtidos pelas análises estatísticas segundo as diferentes farmacopeias resultaram na mesma interpretação final. Na prática, métodos farmacopéicos alternativos permitem ao analista a escolha do cálculo estatístico mais apropriado a ser utilizado.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502012000300024AntibióticosDelineamento por retas paralelasMétodos estatísticos farmacopéicosAntibioticsParallel lines modelPharmacopeial statistical methods |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Miriam de Fátima Vianna Leonel Cristina Duarte Vianna Soares Arminda Lucia Siqueira |
spellingShingle |
Miriam de Fátima Vianna Leonel Cristina Duarte Vianna Soares Arminda Lucia Siqueira Comparison of pharmacopeial statistical methods applied in microbiological assay for antibiotics potency determination using parallel lines and three-dose level Brazilian Journal of Pharmaceutical Sciences Antibióticos Delineamento por retas paralelas Métodos estatísticos farmacopéicos Antibiotics Parallel lines model Pharmacopeial statistical methods |
author_facet |
Miriam de Fátima Vianna Leonel Cristina Duarte Vianna Soares Arminda Lucia Siqueira |
author_sort |
Miriam de Fátima Vianna Leonel |
title |
Comparison of pharmacopeial statistical methods applied in microbiological assay for antibiotics potency determination using parallel lines and three-dose level |
title_short |
Comparison of pharmacopeial statistical methods applied in microbiological assay for antibiotics potency determination using parallel lines and three-dose level |
title_full |
Comparison of pharmacopeial statistical methods applied in microbiological assay for antibiotics potency determination using parallel lines and three-dose level |
title_fullStr |
Comparison of pharmacopeial statistical methods applied in microbiological assay for antibiotics potency determination using parallel lines and three-dose level |
title_full_unstemmed |
Comparison of pharmacopeial statistical methods applied in microbiological assay for antibiotics potency determination using parallel lines and three-dose level |
title_sort |
comparison of pharmacopeial statistical methods applied in microbiological assay for antibiotics potency determination using parallel lines and three-dose level |
publisher |
Universidade de São Paulo |
series |
Brazilian Journal of Pharmaceutical Sciences |
issn |
1984-8250 2175-9790 |
publishDate |
2012-09-01 |
description |
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 Pharmacopeia (4th edition, 1988), British Pharmacopoeia 2011, European Pharmacopoeia (7th edition), The International Pharmacopoeia (4th edition), and United States Pharmacopeia (34th edition). The assay is illustrated with the antibiotic ofloxacin, and details on orthogonal coefficients, normality test, homogeneity of variance test, and detection of outliers are discussed. The calculations obtained by statistical analyses from different pharmacopeias lead to the same final interpretation. In practice, with the availability of alternative pharmacopeial methods, the analyst can choose the most appropriate statistical calculation to be used.<br>Os estudos de equivalência farmacêutica, úteis na verificação da intercambialidade entre os medicamentos genéricos e respectivos medicamentos de referência, têm sido realizados no Brasil desde 1999, como consequência do estabelecimento da política de medicamentos genéricos. Para medicamentos contendo antibióticos, os ensaios microbiológicos são, muitas vezes, o método mais adequado. Entretanto, os métodos estatísticos aplicados nesses ensaios não são amplamente conhecidos devido à dificuldade de acesso aos compêndios oficiais e/ou pouca compreensão das ferramentas estatísticas de análises. Portanto, o objetivo desse trabalho foi comparar os métodos estatísticos para determinação de potência de antibióticos pelo delineamento por retas paralelas e três níveis de doses, descritos nas farmacopeias Brasileira 4. ed. (1988), Britânica 2011, Europeia 7. ed., Internacional 4. ed. e na Farmacopeia dos Estados Unidos 34. ed. (2011). O ensaio é exemplificado com o antibiótico ofloxacino e detalhes sobre coeficientes ortogonais, teste de normalidade, teste de homogeneidade de variância e detecção de outliers são discutidos. Os cálculos obtidos pelas análises estatísticas segundo as diferentes farmacopeias resultaram na mesma interpretação final. Na prática, métodos farmacopéicos alternativos permitem ao analista a escolha do cálculo estatístico mais apropriado a ser utilizado. |
topic |
Antibióticos Delineamento por retas paralelas Métodos estatísticos farmacopéicos Antibiotics Parallel lines model Pharmacopeial statistical methods |
url |
http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502012000300024 |
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