Farmacovigilância no Brasil: A relação entre polimorfismo de fármacos, efetividade e segurança dos medicamentos

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dc.contributor.authorCapucho, Helaine Carneiro
dc.contributor.authorMastroianni, Patricia de Carvalho [UNESP]
dc.contributor.authorCuffini, S.
dc.contributor.institutionUniversidade de São Paulo (USP)
dc.contributor.institutionUniversidade Estadual Paulista (Unesp)
dc.contributor.institutionUnidade Ceprocor
dc.date.accessioned2014-05-27T11:23:46Z
dc.date.available2014-05-27T11:23:46Z
dc.date.issued2008-12-01
dc.description.abstractIn spite of the stated Brazilian policy on medicines that their quality, effectiveness and safety should be ensured at reasonable cost, hospitals in the ANVISA Surveillance Network have been receiving notifications of technical complaints, adverse reactions and suspected therapeutic ineffectiveness (STI) of medicines. The purpose of this study was to identify the medicines notified for suspicion of therapeutic ineffectiveness, at a university hospital participating in the national Surveillance Network, and to investigate the existence of polymorphs of any of the drugs involved, by examining the literature. There were 31 notifications of STI in a period of 18 months, concerning 11 different drugs, all of which were 'similar' drugs (neither original nor licensed by originator); five of these could contain polymorphs, according to the literature. However, this does not mean that the other drugs could not contain some unknown polymorphs, more studies being needed on polymorphism, especially in the cases of reported therapeutic ineffectiveness. Therefore, tests of polymorphism should be made part of the routine quality control of the raw materials during the development of medicines and in the studies of pharmaceutical equivalence to 'reference' medicines (innovative brands). The stability test should also involve a study of polymorphism, in order to confirm the solid state stability of the drug. All these measures will assure the effectiveness of medicines, since the reproducibility in the quality of pharmaceutical products could be monitored, as well as the equivalence of each production batch with the batch selected to determine the bioequivalence with the reference brand.en
dc.description.affiliationGerenciamento de Risco Centro Integrado da Qualidade Universidade de São Paulo, USP, Av. Bandeirantes, no 3.900, CEP: 14048-900 - Ribeirão Preto - SP
dc.description.affiliationDepartamento de Fármacos e Medicamentos Faculdade de Ciências Farmacêuticas Universidade Estadual Paulista, UNESP, Araraquara, SP
dc.description.affiliationAgência Córdoba Ciência Unidade Ceprocor, Córdoba
dc.description.affiliationUnespDepartamento de Fármacos e Medicamentos Faculdade de Ciências Farmacêuticas Universidade Estadual Paulista, UNESP, Araraquara, SP
dc.format.extent277-283
dc.identifierhttp://serv-bib.fcfar.unesp.br/seer/index.php/Cien_Farm/article/view/595
dc.identifier.citationRevista de Ciencias Farmaceuticas Basica e Aplicada, v. 29, n. 3, p. 277-283, 2008.
dc.identifier.file2-s2.0-70349094441.pdf
dc.identifier.issn1808-4532
dc.identifier.lattes4160558780902988
dc.identifier.orcid0000-0001-8467-7278
dc.identifier.scopus2-s2.0-70349094441
dc.identifier.urihttp://hdl.handle.net/11449/70775
dc.language.isopor
dc.relation.ispartofRevista de Ciências Farmacêuticas Básica e Aplicada
dc.relation.ispartofsjr0,131
dc.rights.accessRightsAcesso aberto
dc.sourceScopus
dc.subject'Similar' drug
dc.subjectGeneric drug
dc.subjectHealth surveillance
dc.subjectPolymorphism
dc.subjectbioequivalence
dc.subjectBrazil
dc.subjectdrug efficacy
dc.subjectdrug manufacture
dc.subjectdrug safety
dc.subjectdrug stability
dc.subjectdrug surveillance program
dc.subjectlicence
dc.subjectpolicy
dc.subjectquality control
dc.subjectreproducibility
dc.subjectsolid state
dc.subjectuniversity hospital
dc.titleFarmacovigilância no Brasil: A relação entre polimorfismo de fármacos, efetividade e segurança dos medicamentospt
dc.title.alternativePharmacovigilance in Brazil: The relationship between drug polymorphism and the effectiveness and safety of medicinesen
dc.typeArtigo
dcterms.licensehttp://serv-bib.fcfar.unesp.br/seer/index.php/Cien_Farm/about
unesp.author.lattes4160558780902988[2]
unesp.author.orcid0000-0001-8467-7278[2]
unesp.campusUniversidade Estadual Paulista (Unesp), Faculdade de Ciências Farmacêuticas, Araraquarapt

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Artigos - Fármacos e Medicamentos - FCFAR