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dc.contributor.author
Maggio, Ruben Mariano
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dc.contributor.author
Castellano, Patricia Margarita
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dc.contributor.author
Kaufman, Teodoro Saul
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dc.date.available
2021-07-26T15:01:57Z
dc.date.issued
2008-05
dc.identifier.citation
Maggio, Ruben Mariano; Castellano, Patricia Margarita; Kaufman, Teodoro Saul; A new principal component analysis-based approach for testing "similarity" of drug dissolution profiles; Elsevier Science; European Journal of Pharmaceutical Sciences; 34; 1; 5-2008; 66-77
dc.identifier.issn
0928-0987
dc.identifier.uri
http://hdl.handle.net/11336/136928
dc.description.abstract
A new approach for testing batch "similarity" through comparison of drug dissolution profiles, based on principal component analysis with the establishment of a confidence region (PCA-CR), is presented. The dissolution curves corresponding to three brands each of Furosemide and Acetaminophen tablets, taken as model drugs, were prepared by dissolution measurements at multiple pre-specified time points. Reference and test data were simultaneously subjected to PCA and pairwise comparisons between the dissolution characteristics of lots of the same and different brands were carried out. The comparisons involved plotting the weighed scores of the first two principal components of reference and test lots, while decision about "similarity" was made by checking for inclusion of more than 80% of the tablets of the test lot in the 95% confidence ellipse of the reference samples. Two published datasets were also analyzed in the same fashion and all the results were compared with information provided by the difference (f1) and similarity (f2) factor tests. Unlike the f2 criterion, the proposed method reflects variability within the individual dissolution curves, being also highly sensitive to profile (shape and size) variations. Comparison between the area enclosed by the confidence ellipses of the weighed scores plot and the region obtained from the bootstrap-calculated acceptable values of the corresponding f2 tests suggested that PCA-CR represents, in general, a more discriminating standard.
dc.format
application/pdf
dc.language.iso
eng
dc.publisher
Elsevier Science
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dc.rights
info:eu-repo/semantics/openAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
dc.subject
ACETAMINOPHEN
dc.subject
DISSOLUTION PROFILES
dc.subject
FUROSEMIDE
dc.subject
MULTIVARIATE METHOD
dc.subject
PRINCIPAL COMPONENT ANALYSIS
dc.subject
SIMILARITY TEST
dc.subject.classification
Química Orgánica
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dc.subject.classification
Ciencias Químicas
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dc.subject.classification
CIENCIAS NATURALES Y EXACTAS
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dc.title
A new principal component analysis-based approach for testing "similarity" of drug dissolution profiles
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2021-06-07T16:15:00Z
dc.journal.volume
34
dc.journal.number
1
dc.journal.pagination
66-77
dc.journal.pais
Países Bajos
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dc.journal.ciudad
Amsterdam
dc.description.fil
Fil: Maggio, Ruben Mariano. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
dc.description.fil
Fil: Castellano, Patricia Margarita. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
dc.description.fil
Fil: Kaufman, Teodoro Saul. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
dc.journal.title
European Journal of Pharmaceutical Sciences
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dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/abs/pii/S0928098708000602?via%3Dihub
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1016/j.ejps.2008.02.009
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