Bioequivalence Study of Imatinib Formulations that Contain 400 mg in Healthy Colombians

5 páginas

Autores:: Vargas M.
Villarraga E.

Tipo de recurso:

Fecha de publicación:: 2017

Institución:: Universidad de la Sabana

Repositorio:: Repositorio Universidad de la Sabana

Idioma:: eng

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spelling	Vargas M.Villarraga E.10/7/2019 13:592019-10-07T18:59:59Z2017Vargas M, Villarraga E (2017) Bioequivalence Study of Imatinib Formulations that Contain 400 mg in Healthy Colombians. J Bioequiv Availab 9: 483-488. doi: 10.4172/jbb.1000349https://www.longdom.org/open-access/bioequivalence-study-of-imatinib-formulations-that-contain-400-mg-in-healthy-colombians-jbb-1000349.pdfhttp://hdl.handle.net/10818/3754510.4172/jbb.10003495 páginasA study with the aim to compare the bioavailability of two 400 mg imatinib formulations, test product Zeite® from Laboratorio Synthesis S.A.S., Colombia, and reference product Glivec® from Novartis Pharma, and determine if bioequivalence can be declared, was runned. It was an open, four periods and two pre-randomized sequences, crossed study, with a 400mg single dose in fastened and fed conditions, in 30 healthy Colombian volunteers; wash time was 7 days in between periods, with sampling between 0 and 72 hours after drug administration, which was randomly administered in each period. The analytical method used was high performance liquid chromatography with ultraviolet detector, HPLC UV for plasma identification and quantification of imatinib. The confidence interval of 90% of parameters Cmax, AUCall and AUC0-Inf, were taken to statistical analysis and were found, according to the european guidelines for research, which allowed to declare bioequivalence and interchangeability between the products from Laboratorios Synthesis S.A.S. and the reference product from Laboratory Novartis Pharmaapplication/pdfengJournal of Bioequivalence & BioavailabilityBioequiv Availab 2017, 9:5Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/http://purl.org/coar/access_right/c_abf2Universidad de La SabanaIntellectum Repositorio Universidad de La SabanaBioequivalenceImatinibOncologicPharmacokineticsBioequivalence Study of Imatinib Formulations that Contain 400 mg in Healthy ColombiansarticlepublishedVersionhttp://purl.org/coar/version/c_970fb48d4fbd8a85http://purl.org/coar/resource_type/c_6501CC-LICENSElicense_rdflicense_rdfapplication/rdf+xml; charset=utf-8805https://intellectum.unisabana.edu.co/bitstream/10818/37545/2/license_rdf4460e5956bc1d1639be9ae6146a50347MD52LICENSElicense.txtlicense.txttext/plain; charset=utf-8498https://intellectum.unisabana.edu.co/bitstream/10818/37545/3/license.txtf52a2cfd4df262e08e9b300d62c85cabMD5310818/37545oai:intellectum.unisabana.edu.co:10818/375452022-05-10 05:19:20.582Intellectum Universidad de la Sabanacontactointellectum@unisabana.edu.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
dc.title.es_CO.fl_str_mv	Bioequivalence Study of Imatinib Formulations that Contain 400 mg in Healthy Colombians
title	Bioequivalence Study of Imatinib Formulations that Contain 400 mg in Healthy Colombians
spellingShingle	Bioequivalence Study of Imatinib Formulations that Contain 400 mg in Healthy Colombians Bioequivalence Imatinib Oncologic Pharmacokinetics
title_short	Bioequivalence Study of Imatinib Formulations that Contain 400 mg in Healthy Colombians
title_full	Bioequivalence Study of Imatinib Formulations that Contain 400 mg in Healthy Colombians
title_fullStr	Bioequivalence Study of Imatinib Formulations that Contain 400 mg in Healthy Colombians
title_full_unstemmed	Bioequivalence Study of Imatinib Formulations that Contain 400 mg in Healthy Colombians
title_sort	Bioequivalence Study of Imatinib Formulations that Contain 400 mg in Healthy Colombians
dc.creator.fl_str_mv	Vargas M. Villarraga E.
dc.contributor.author.none.fl_str_mv	Vargas M. Villarraga E.
dc.subject.es_CO.fl_str_mv	Bioequivalence Imatinib Oncologic Pharmacokinetics
topic	Bioequivalence Imatinib Oncologic Pharmacokinetics
description	5 páginas
publishDate	2017
dc.date.accessioned.none.fl_str_mv	10/7/2019 13:59
dc.date.issued.none.fl_str_mv	2017
dc.date.available.none.fl_str_mv	2019-10-07T18:59:59Z
dc.type.en.fl_str_mv	article
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dc.identifier.citation.es_CO.fl_str_mv	Vargas M, Villarraga E (2017) Bioequivalence Study of Imatinib Formulations that Contain 400 mg in Healthy Colombians. J Bioequiv Availab 9: 483-488. doi: 10.4172/jbb.1000349
dc.identifier.other.none.fl_str_mv	https://www.longdom.org/open-access/bioequivalence-study-of-imatinib-formulations-that-contain-400-mg-in-healthy-colombians-jbb-1000349.pdf
dc.identifier.uri.none.fl_str_mv	http://hdl.handle.net/10818/37545
dc.identifier.doi.none.fl_str_mv	10.4172/jbb.1000349
identifier_str_mv	Vargas M, Villarraga E (2017) Bioequivalence Study of Imatinib Formulations that Contain 400 mg in Healthy Colombians. J Bioequiv Availab 9: 483-488. doi: 10.4172/jbb.1000349 10.4172/jbb.1000349
url	https://www.longdom.org/open-access/bioequivalence-study-of-imatinib-formulations-that-contain-400-mg-in-healthy-colombians-jbb-1000349.pdf http://hdl.handle.net/10818/37545
dc.language.iso.es_CO.fl_str_mv	eng
language	eng
dc.relation.ispartofseries.none.fl_str_mv	Bioequiv Availab 2017, 9:5
dc.rights.*.fl_str_mv	Attribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.coar.fl_str_mv	http://purl.org/coar/access_right/c_abf2
dc.rights.uri.*.fl_str_mv	http://creativecommons.org/licenses/by-nc-nd/4.0/
rights_invalid_str_mv	Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ http://purl.org/coar/access_right/c_abf2
dc.format.es_CO.fl_str_mv	application/pdf
dc.publisher.es_CO.fl_str_mv	Journal of Bioequivalence & Bioavailability
dc.source.es_CO.fl_str_mv	Universidad de La Sabana Intellectum Repositorio Universidad de La Sabana
institution	Universidad de la Sabana
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Bioequivalence Study of Imatinib Formulations that Contain 400 mg in Healthy Colombians

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