Analysis of the biorelevance of the main methods used to compare in vitro dissolution profiles

Autores
Ruiz, María Esperanza
Año de publicación
2013
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
The article analyzes comparatively the performance of the main methods proposed for the comparison of percent dissolved vs. time curves: model-dependent, model-independent and ANOVA-based statistical methods. In particular, it discusses the biorelevance of those methods when applied for the comparison of dissolution profiles of multisource drug products. As a conclusion, the use of a combined-approach between model-independent methods are encouraged, based on the analysis of in vitro dissolution profiles of several brands of oral solid dosage forms of different drugs and on the comparison of those results with previously published in vivo results.
Fil: Ruiz, María Esperanza. Universidad Nacional de la Plata. Facultad de Cs.exactas. Departamento de Cs.biologicas. Catedra de Control de Calidad de Medicamentos; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico La Plata. Centro de Investigación y Desarrollo en Ciencias Aplicadas; Argentina
Materia
Dissolution Profiles
F2 Factor
Biopharmacy
Methods to Compare Curves
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/4848
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/4848
network_acronym_str CONICETDig
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network_name_str CONICET Digital (CONICET)
spelling Analysis of the biorelevance of the main methods used to compare in vitro dissolution profilesRuiz, María EsperanzaDissolution ProfilesF2 FactorBiopharmacyMethods to Compare Curveshttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3The article analyzes comparatively the performance of the main methods proposed for the comparison of percent dissolved vs. time curves: model-dependent, model-independent and ANOVA-based statistical methods. In particular, it discusses the biorelevance of those methods when applied for the comparison of dissolution profiles of multisource drug products. As a conclusion, the use of a combined-approach between model-independent methods are encouraged, based on the analysis of in vitro dissolution profiles of several brands of oral solid dosage forms of different drugs and on the comparison of those results with previously published in vivo results.Fil: Ruiz, María Esperanza. Universidad Nacional de la Plata. Facultad de Cs.exactas. Departamento de Cs.biologicas. Catedra de Control de Calidad de Medicamentos; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico La Plata. Centro de Investigación y Desarrollo en Ciencias Aplicadas; ArgentinaCompareNetworks2013-12info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/octet-streamapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/4848Ruiz, María Esperanza; Analysis of the biorelevance of the main methods used to compare in vitro dissolution profiles; CompareNetworks; American Pharmaceutical Review; 16; 7; 12-2013; 30-331099-8012enginfo:eu-repo/semantics/altIdentifier/url/http://goo.gl/ZLxDkainfo:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T10:04:34Zoai:ri.conicet.gov.ar:11336/4848instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-03 10:04:34.561CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Analysis of the biorelevance of the main methods used to compare in vitro dissolution profiles
title Analysis of the biorelevance of the main methods used to compare in vitro dissolution profiles
spellingShingle Analysis of the biorelevance of the main methods used to compare in vitro dissolution profiles
Ruiz, María Esperanza
Dissolution Profiles
F2 Factor
Biopharmacy
Methods to Compare Curves
title_short Analysis of the biorelevance of the main methods used to compare in vitro dissolution profiles
title_full Analysis of the biorelevance of the main methods used to compare in vitro dissolution profiles
title_fullStr Analysis of the biorelevance of the main methods used to compare in vitro dissolution profiles
title_full_unstemmed Analysis of the biorelevance of the main methods used to compare in vitro dissolution profiles
title_sort Analysis of the biorelevance of the main methods used to compare in vitro dissolution profiles
dc.creator.none.fl_str_mv Ruiz, María Esperanza
author Ruiz, María Esperanza
author_facet Ruiz, María Esperanza
author_role author
dc.subject.none.fl_str_mv Dissolution Profiles
F2 Factor
Biopharmacy
Methods to Compare Curves
topic Dissolution Profiles
F2 Factor
Biopharmacy
Methods to Compare Curves
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv The article analyzes comparatively the performance of the main methods proposed for the comparison of percent dissolved vs. time curves: model-dependent, model-independent and ANOVA-based statistical methods. In particular, it discusses the biorelevance of those methods when applied for the comparison of dissolution profiles of multisource drug products. As a conclusion, the use of a combined-approach between model-independent methods are encouraged, based on the analysis of in vitro dissolution profiles of several brands of oral solid dosage forms of different drugs and on the comparison of those results with previously published in vivo results.
Fil: Ruiz, María Esperanza. Universidad Nacional de la Plata. Facultad de Cs.exactas. Departamento de Cs.biologicas. Catedra de Control de Calidad de Medicamentos; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico La Plata. Centro de Investigación y Desarrollo en Ciencias Aplicadas; Argentina
description The article analyzes comparatively the performance of the main methods proposed for the comparison of percent dissolved vs. time curves: model-dependent, model-independent and ANOVA-based statistical methods. In particular, it discusses the biorelevance of those methods when applied for the comparison of dissolution profiles of multisource drug products. As a conclusion, the use of a combined-approach between model-independent methods are encouraged, based on the analysis of in vitro dissolution profiles of several brands of oral solid dosage forms of different drugs and on the comparison of those results with previously published in vivo results.
publishDate 2013
dc.date.none.fl_str_mv 2013-12
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/4848
Ruiz, María Esperanza; Analysis of the biorelevance of the main methods used to compare in vitro dissolution profiles; CompareNetworks; American Pharmaceutical Review; 16; 7; 12-2013; 30-33
1099-8012
url http://hdl.handle.net/11336/4848
identifier_str_mv Ruiz, María Esperanza; Analysis of the biorelevance of the main methods used to compare in vitro dissolution profiles; CompareNetworks; American Pharmaceutical Review; 16; 7; 12-2013; 30-33
1099-8012
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/http://goo.gl/ZLxDka
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/octet-stream
application/pdf
application/pdf
dc.publisher.none.fl_str_mv CompareNetworks
publisher.none.fl_str_mv CompareNetworks
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
_version_ 1842269863424294912
score 13.13397

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