Profile of adverse events in bioequivalence trials at the Clinical Pharmacology Unit since 2000 to 2003
Autor(a) principal: | |
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Data de Publicação: | 2004 |
Tipo de documento: | Dissertação |
Idioma: | por |
Título da fonte: | Biblioteca Digital de Teses e Dissertações da UFC |
Texto Completo: | http://www.teses.ufc.br/tde_busca/arquivo.php?codArquivo=146 |
Resumo: | The inexistence of medicines that act only in one target cell leads to a possible interaction at others cell structures which are not related to their therapeutic action, coming to the appearance of adverse drug reactions (ADR). The Pharmacovigillance System may lead to a better ADR analysis at a health or research institution, making itself essential for adverse events (AE) registering throughout clinical trials and more efficient investigation and notification afterwards. With the objective of evaluation of AE registered during bioequivalence trials, it was done a retrospective analysis of the voluntaries profiles from these trials in the period of 2000 to 2003. It was evaluated the frequency and the incidence of the events observed from the main pharmacological groups involved in the trials. For the two events more frequent from each pharmacological group, it was evaluated their causuality registered according to the present information found at the scientific literature. A total of 625 AE were analyzed with a mean value of 156 events per year, an incidence of 55,8% of AE per trial and a frequency of 13,89%. To make a standard causuality classification, it was proposed a specific classificatory model for bioequivalence trials. Therefore, the implementation of a standard method for AE causuality classification is essential for a better interpretation and safer notification of ADR. |
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info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisProfile of adverse events in bioequivalence trials at the Clinical Pharmacology Unit since 2000 to 2003Perfil dos eventos adversos registrados nos estudos de bioequivalÃncia realizados na Unidade de Farmacologia ClÃnica no perÃodo de 2000 a 2003 2004-05-14Maria Elisabete Amaral de Moraes09041389334http://lattes.cnpq.br/3565768281344086Helena Serra Azul Monteiro03277470300http://lattes.cnpq.br/3830155707659519Alice Maria Costa Martins43431690300http://lattes.cnpq.br/753233462026457768645171287http://buscatextual.cnpq.br/buscatextual/visualizacv.jsp?id=K4770474A2Giovanni Carvalho GuzzoUniversidade Federal do CearÃPrograma de PÃs-GraduaÃÃo em FarmacologiaUFCBREnsaios ClÃnicos Evento adverso ReaÃÃo adversa CausalidadeClinical trial Bioequivalence Adverse event Adverse reaction CausalityFARMACOLOGIAThe inexistence of medicines that act only in one target cell leads to a possible interaction at others cell structures which are not related to their therapeutic action, coming to the appearance of adverse drug reactions (ADR). The Pharmacovigillance System may lead to a better ADR analysis at a health or research institution, making itself essential for adverse events (AE) registering throughout clinical trials and more efficient investigation and notification afterwards. With the objective of evaluation of AE registered during bioequivalence trials, it was done a retrospective analysis of the voluntaries profiles from these trials in the period of 2000 to 2003. It was evaluated the frequency and the incidence of the events observed from the main pharmacological groups involved in the trials. For the two events more frequent from each pharmacological group, it was evaluated their causuality registered according to the present information found at the scientific literature. A total of 625 AE were analyzed with a mean value of 156 events per year, an incidence of 55,8% of AE per trial and a frequency of 13,89%. To make a standard causuality classification, it was proposed a specific classificatory model for bioequivalence trials. Therefore, the implementation of a standard method for AE causuality classification is essential for a better interpretation and safer notification of ADR.A inexistÃncia de medicamentos que atuem exclusivamente em um Ãnico alvo celular permite a possÃvel interaÃÃo com outras estruturas que nÃo estÃo relacionadas com sua aÃÃo terapÃutica, vindo a gerar reaÃÃes adversas a medicamentos (RAM). O sistema da FarmacovigilÃncia viabiliza uma melhor anÃlise de RAM em uma instituiÃÃo de saÃde ou de pesquisa necessita, tornando-se fundamental para o registro de eventos adversos durante estudos clÃnicos, posterior investigaÃÃo e notificaÃÃo dos mesmos. Com o objetivo de avaliar os registros de eventos adversos de ensaios clÃnicos de bioequivalÃncia, realizou-se uma anÃlise retrospectiva dos prontuÃrios de voluntÃrios desses ensaios no perÃodo de 2000 a 2003. Foram avaliadas a freqÃÃncia e a incidÃncia dos eventos observados dos principais grupos farmacolÃgicos envolvidos nos ensaios. Para os dois eventos mais freqÃentes de cada grupo farmacolÃgico, avaliou-se sua causalidade registrada no estudo com as informaÃÃes presentes na literatura cientÃfica. Um total de 625 eventos adversos foram analisados, com uma mÃdia de 156 eventos por ano, incidÃncia de 55,8% de eventos adversos por ensaio e freqÃÃncia de 13,89%. Para a padronizaÃÃo da classificaÃÃo de causalidade, propÃs-se um modelo classificatÃrio especÃfico para ensaios de bioequivalÃncia Faz-se, entÃo, viÃvel a implementaÃÃo de um mÃtodo padronizado de classificaÃÃo de causalidade de eventos adversos para uma melhor interpretaÃÃo e notificaÃÃo segura de reaÃÃes adversas.Conselho Nacional de Desenvolvimento CientÃfico e TecnolÃgicohttp://www.teses.ufc.br/tde_busca/arquivo.php?codArquivo=146application/pdfinfo:eu-repo/semantics/openAccessporreponame:Biblioteca Digital de Teses e Dissertações da UFCinstname:Universidade Federal do Cearáinstacron:UFC2019-01-21T11:13:14Zmail@mail.com - |
dc.title.en.fl_str_mv |
Profile of adverse events in bioequivalence trials at the Clinical Pharmacology Unit since 2000 to 2003 |
dc.title.alternative.pt.fl_str_mv |
Perfil dos eventos adversos registrados nos estudos de bioequivalÃncia realizados na Unidade de Farmacologia ClÃnica no perÃodo de 2000 a 2003 |
title |
Profile of adverse events in bioequivalence trials at the Clinical Pharmacology Unit since 2000 to 2003 |
spellingShingle |
Profile of adverse events in bioequivalence trials at the Clinical Pharmacology Unit since 2000 to 2003 Giovanni Carvalho Guzzo Ensaios ClÃnicos Evento adverso ReaÃÃo adversa Causalidade Clinical trial Bioequivalence Adverse event Adverse reaction Causality FARMACOLOGIA |
title_short |
Profile of adverse events in bioequivalence trials at the Clinical Pharmacology Unit since 2000 to 2003 |
title_full |
Profile of adverse events in bioequivalence trials at the Clinical Pharmacology Unit since 2000 to 2003 |
title_fullStr |
Profile of adverse events in bioequivalence trials at the Clinical Pharmacology Unit since 2000 to 2003 |
title_full_unstemmed |
Profile of adverse events in bioequivalence trials at the Clinical Pharmacology Unit since 2000 to 2003 |
title_sort |
Profile of adverse events in bioequivalence trials at the Clinical Pharmacology Unit since 2000 to 2003 |
author |
Giovanni Carvalho Guzzo |
author_facet |
Giovanni Carvalho Guzzo |
author_role |
author |
dc.contributor.advisor1.fl_str_mv |
Maria Elisabete Amaral de Moraes |
dc.contributor.advisor1ID.fl_str_mv |
09041389334 |
dc.contributor.advisor1Lattes.fl_str_mv |
http://lattes.cnpq.br/3565768281344086 |
dc.contributor.referee1.fl_str_mv |
Helena Serra Azul Monteiro |
dc.contributor.referee1ID.fl_str_mv |
03277470300 |
dc.contributor.referee1Lattes.fl_str_mv |
http://lattes.cnpq.br/3830155707659519 |
dc.contributor.referee2.fl_str_mv |
Alice Maria Costa Martins |
dc.contributor.referee2ID.fl_str_mv |
43431690300 |
dc.contributor.referee2Lattes.fl_str_mv |
http://lattes.cnpq.br/7532334620264577 |
dc.contributor.authorID.fl_str_mv |
68645171287 |
dc.contributor.authorLattes.fl_str_mv |
http://buscatextual.cnpq.br/buscatextual/visualizacv.jsp?id=K4770474A2 |
dc.contributor.author.fl_str_mv |
Giovanni Carvalho Guzzo |
contributor_str_mv |
Maria Elisabete Amaral de Moraes Helena Serra Azul Monteiro Alice Maria Costa Martins |
dc.subject.por.fl_str_mv |
Ensaios ClÃnicos Evento adverso ReaÃÃo adversa Causalidade |
topic |
Ensaios ClÃnicos Evento adverso ReaÃÃo adversa Causalidade Clinical trial Bioequivalence Adverse event Adverse reaction Causality FARMACOLOGIA |
dc.subject.eng.fl_str_mv |
Clinical trial Bioequivalence Adverse event Adverse reaction Causality |
dc.subject.cnpq.fl_str_mv |
FARMACOLOGIA |
dc.description.sponsorship.fl_txt_mv |
Conselho Nacional de Desenvolvimento CientÃfico e TecnolÃgico |
dc.description.abstract.por.fl_txt_mv |
The inexistence of medicines that act only in one target cell leads to a possible interaction at others cell structures which are not related to their therapeutic action, coming to the appearance of adverse drug reactions (ADR). The Pharmacovigillance System may lead to a better ADR analysis at a health or research institution, making itself essential for adverse events (AE) registering throughout clinical trials and more efficient investigation and notification afterwards. With the objective of evaluation of AE registered during bioequivalence trials, it was done a retrospective analysis of the voluntaries profiles from these trials in the period of 2000 to 2003. It was evaluated the frequency and the incidence of the events observed from the main pharmacological groups involved in the trials. For the two events more frequent from each pharmacological group, it was evaluated their causuality registered according to the present information found at the scientific literature. A total of 625 AE were analyzed with a mean value of 156 events per year, an incidence of 55,8% of AE per trial and a frequency of 13,89%. To make a standard causuality classification, it was proposed a specific classificatory model for bioequivalence trials. Therefore, the implementation of a standard method for AE causuality classification is essential for a better interpretation and safer notification of ADR. A inexistÃncia de medicamentos que atuem exclusivamente em um Ãnico alvo celular permite a possÃvel interaÃÃo com outras estruturas que nÃo estÃo relacionadas com sua aÃÃo terapÃutica, vindo a gerar reaÃÃes adversas a medicamentos (RAM). O sistema da FarmacovigilÃncia viabiliza uma melhor anÃlise de RAM em uma instituiÃÃo de saÃde ou de pesquisa necessita, tornando-se fundamental para o registro de eventos adversos durante estudos clÃnicos, posterior investigaÃÃo e notificaÃÃo dos mesmos. Com o objetivo de avaliar os registros de eventos adversos de ensaios clÃnicos de bioequivalÃncia, realizou-se uma anÃlise retrospectiva dos prontuÃrios de voluntÃrios desses ensaios no perÃodo de 2000 a 2003. Foram avaliadas a freqÃÃncia e a incidÃncia dos eventos observados dos principais grupos farmacolÃgicos envolvidos nos ensaios. Para os dois eventos mais freqÃentes de cada grupo farmacolÃgico, avaliou-se sua causalidade registrada no estudo com as informaÃÃes presentes na literatura cientÃfica. Um total de 625 eventos adversos foram analisados, com uma mÃdia de 156 eventos por ano, incidÃncia de 55,8% de eventos adversos por ensaio e freqÃÃncia de 13,89%. Para a padronizaÃÃo da classificaÃÃo de causalidade, propÃs-se um modelo classificatÃrio especÃfico para ensaios de bioequivalÃncia Faz-se, entÃo, viÃvel a implementaÃÃo de um mÃtodo padronizado de classificaÃÃo de causalidade de eventos adversos para uma melhor interpretaÃÃo e notificaÃÃo segura de reaÃÃes adversas. |
description |
The inexistence of medicines that act only in one target cell leads to a possible interaction at others cell structures which are not related to their therapeutic action, coming to the appearance of adverse drug reactions (ADR). The Pharmacovigillance System may lead to a better ADR analysis at a health or research institution, making itself essential for adverse events (AE) registering throughout clinical trials and more efficient investigation and notification afterwards. With the objective of evaluation of AE registered during bioequivalence trials, it was done a retrospective analysis of the voluntaries profiles from these trials in the period of 2000 to 2003. It was evaluated the frequency and the incidence of the events observed from the main pharmacological groups involved in the trials. For the two events more frequent from each pharmacological group, it was evaluated their causuality registered according to the present information found at the scientific literature. A total of 625 AE were analyzed with a mean value of 156 events per year, an incidence of 55,8% of AE per trial and a frequency of 13,89%. To make a standard causuality classification, it was proposed a specific classificatory model for bioequivalence trials. Therefore, the implementation of a standard method for AE causuality classification is essential for a better interpretation and safer notification of ADR. |
publishDate |
2004 |
dc.date.issued.fl_str_mv |
2004-05-14 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/masterThesis |
status_str |
publishedVersion |
format |
masterThesis |
dc.identifier.uri.fl_str_mv |
http://www.teses.ufc.br/tde_busca/arquivo.php?codArquivo=146 |
url |
http://www.teses.ufc.br/tde_busca/arquivo.php?codArquivo=146 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Universidade Federal do Cearà |
dc.publisher.program.fl_str_mv |
Programa de PÃs-GraduaÃÃo em Farmacologia |
dc.publisher.initials.fl_str_mv |
UFC |
dc.publisher.country.fl_str_mv |
BR |
publisher.none.fl_str_mv |
Universidade Federal do Cearà |
dc.source.none.fl_str_mv |
reponame:Biblioteca Digital de Teses e Dissertações da UFC instname:Universidade Federal do Ceará instacron:UFC |
reponame_str |
Biblioteca Digital de Teses e Dissertações da UFC |
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Biblioteca Digital de Teses e Dissertações da UFC |
instname_str |
Universidade Federal do Ceará |
instacron_str |
UFC |
institution |
UFC |
repository.name.fl_str_mv |
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|
repository.mail.fl_str_mv |
mail@mail.com |
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1643295113383772160 |