ELABORATION OF GUIDELINE FOR MONITORING IN RELATIVE BIOAVAILABILITY / PHARMACEUTICAL BIOEQUIVALENCE STUDY BY THE SPONSOR
Autor(a) principal: | |
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Data de Publicação: | 2022 |
Outros Autores: | , , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Arquivos de Ciências da Saúde da UNIPAR (Online) |
Texto Completo: | https://revistas.unipar.br/index.php/saude/article/view/8400 |
Resumo: | For registration of generic and similar drugs, it is necessary to carry out pharmaceutical equivalence (PE) tests and pharmaceutical bioequivalence (PB). To carry out these tests, duly qualified research centers are contracted, which need to be monitored by the sponsor who is legally responsible for the activities. To this end, it is the recommendation of the Document of the Americas, periodic monitoring to verify compliance with quality requirements, Standard Operating Procedures, Good Clinical Practices (GCP), Good Laboratory Practices (GLP), of the applicable regulatory framework, as well as of compliance with the study protocol. Thus, monitoring is a methodical and documented process to evaluate the degree of adhesion of the center to the planned design for the evaluation of the formulations. To this end, the implementation of a standardized and easily completed guideline is a very important tool to guarantee a consistent evaluation and maintain the organizational memory of the evaluated items by monitors designated by the sponsor, contributing to the constant improvement of the contracted centers and supporting traceability of the studies. This work provided a systemic view of the evidence process related mainly to pharmaceutical bioequivalence, with the monitoring guideline summarizing the items of greatest relevance to be verified. |
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ELABORATION OF GUIDELINE FOR MONITORING IN RELATIVE BIOAVAILABILITY / PHARMACEUTICAL BIOEQUIVALENCE STUDY BY THE SPONSORFor registration of generic and similar drugs, it is necessary to carry out pharmaceutical equivalence (PE) tests and pharmaceutical bioequivalence (PB). To carry out these tests, duly qualified research centers are contracted, which need to be monitored by the sponsor who is legally responsible for the activities. To this end, it is the recommendation of the Document of the Americas, periodic monitoring to verify compliance with quality requirements, Standard Operating Procedures, Good Clinical Practices (GCP), Good Laboratory Practices (GLP), of the applicable regulatory framework, as well as of compliance with the study protocol. Thus, monitoring is a methodical and documented process to evaluate the degree of adhesion of the center to the planned design for the evaluation of the formulations. To this end, the implementation of a standardized and easily completed guideline is a very important tool to guarantee a consistent evaluation and maintain the organizational memory of the evaluated items by monitors designated by the sponsor, contributing to the constant improvement of the contracted centers and supporting traceability of the studies. This work provided a systemic view of the evidence process related mainly to pharmaceutical bioequivalence, with the monitoring guideline summarizing the items of greatest relevance to be verified.UNIPAR2022-09-27info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://revistas.unipar.br/index.php/saude/article/view/840010.25110/arqsaude.v26i3.2022.8400Arquivos de Ciências da Saúde da UNIPAR; v. 26 n. 3 (2022)1982-114X10.25110/arqsaude.v26i3.2022reponame:Arquivos de Ciências da Saúde da UNIPAR (Online)instname:Universidade Paranaense (UNIPAR)instacron:UNIPARporhttps://revistas.unipar.br/index.php/saude/article/view/8400/4313Copyright (c) 2022 Arquivos de Ciências da Saúde da UNIPARinfo:eu-repo/semantics/openAccessGozzi, Paula ThaisBueno, Fernanda GiacominiZimmermann, Patrícia Moura da RosaJunior, Liberato Brum2022-10-26T13:26:32Zoai:ojs2.revistas.unipar.br:article/8400Revistahttp://revistas.unipar.br/index.php/saudehttp://revistas.unipar.br/saude/oai||cedic@unipar.br|| arqsaude@unipar.br1982-114X1415-076Xopendoar:2022-10-26T13:26:32Arquivos de Ciências da Saúde da UNIPAR (Online) - Universidade Paranaense (UNIPAR)false |
dc.title.none.fl_str_mv |
ELABORATION OF GUIDELINE FOR MONITORING IN RELATIVE BIOAVAILABILITY / PHARMACEUTICAL BIOEQUIVALENCE STUDY BY THE SPONSOR |
title |
ELABORATION OF GUIDELINE FOR MONITORING IN RELATIVE BIOAVAILABILITY / PHARMACEUTICAL BIOEQUIVALENCE STUDY BY THE SPONSOR |
spellingShingle |
ELABORATION OF GUIDELINE FOR MONITORING IN RELATIVE BIOAVAILABILITY / PHARMACEUTICAL BIOEQUIVALENCE STUDY BY THE SPONSOR Gozzi, Paula Thais |
title_short |
ELABORATION OF GUIDELINE FOR MONITORING IN RELATIVE BIOAVAILABILITY / PHARMACEUTICAL BIOEQUIVALENCE STUDY BY THE SPONSOR |
title_full |
ELABORATION OF GUIDELINE FOR MONITORING IN RELATIVE BIOAVAILABILITY / PHARMACEUTICAL BIOEQUIVALENCE STUDY BY THE SPONSOR |
title_fullStr |
ELABORATION OF GUIDELINE FOR MONITORING IN RELATIVE BIOAVAILABILITY / PHARMACEUTICAL BIOEQUIVALENCE STUDY BY THE SPONSOR |
title_full_unstemmed |
ELABORATION OF GUIDELINE FOR MONITORING IN RELATIVE BIOAVAILABILITY / PHARMACEUTICAL BIOEQUIVALENCE STUDY BY THE SPONSOR |
title_sort |
ELABORATION OF GUIDELINE FOR MONITORING IN RELATIVE BIOAVAILABILITY / PHARMACEUTICAL BIOEQUIVALENCE STUDY BY THE SPONSOR |
author |
Gozzi, Paula Thais |
author_facet |
Gozzi, Paula Thais Bueno, Fernanda Giacomini Zimmermann, Patrícia Moura da Rosa Junior, Liberato Brum |
author_role |
author |
author2 |
Bueno, Fernanda Giacomini Zimmermann, Patrícia Moura da Rosa Junior, Liberato Brum |
author2_role |
author author author |
dc.contributor.author.fl_str_mv |
Gozzi, Paula Thais Bueno, Fernanda Giacomini Zimmermann, Patrícia Moura da Rosa Junior, Liberato Brum |
description |
For registration of generic and similar drugs, it is necessary to carry out pharmaceutical equivalence (PE) tests and pharmaceutical bioequivalence (PB). To carry out these tests, duly qualified research centers are contracted, which need to be monitored by the sponsor who is legally responsible for the activities. To this end, it is the recommendation of the Document of the Americas, periodic monitoring to verify compliance with quality requirements, Standard Operating Procedures, Good Clinical Practices (GCP), Good Laboratory Practices (GLP), of the applicable regulatory framework, as well as of compliance with the study protocol. Thus, monitoring is a methodical and documented process to evaluate the degree of adhesion of the center to the planned design for the evaluation of the formulations. To this end, the implementation of a standardized and easily completed guideline is a very important tool to guarantee a consistent evaluation and maintain the organizational memory of the evaluated items by monitors designated by the sponsor, contributing to the constant improvement of the contracted centers and supporting traceability of the studies. This work provided a systemic view of the evidence process related mainly to pharmaceutical bioequivalence, with the monitoring guideline summarizing the items of greatest relevance to be verified. |
publishDate |
2022 |
dc.date.none.fl_str_mv |
2022-09-27 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://revistas.unipar.br/index.php/saude/article/view/8400 10.25110/arqsaude.v26i3.2022.8400 |
url |
https://revistas.unipar.br/index.php/saude/article/view/8400 |
identifier_str_mv |
10.25110/arqsaude.v26i3.2022.8400 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
https://revistas.unipar.br/index.php/saude/article/view/8400/4313 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2022 Arquivos de Ciências da Saúde da UNIPAR info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2022 Arquivos de Ciências da Saúde da UNIPAR |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
UNIPAR |
publisher.none.fl_str_mv |
UNIPAR |
dc.source.none.fl_str_mv |
Arquivos de Ciências da Saúde da UNIPAR; v. 26 n. 3 (2022) 1982-114X 10.25110/arqsaude.v26i3.2022 reponame:Arquivos de Ciências da Saúde da UNIPAR (Online) instname:Universidade Paranaense (UNIPAR) instacron:UNIPAR |
instname_str |
Universidade Paranaense (UNIPAR) |
instacron_str |
UNIPAR |
institution |
UNIPAR |
reponame_str |
Arquivos de Ciências da Saúde da UNIPAR (Online) |
collection |
Arquivos de Ciências da Saúde da UNIPAR (Online) |
repository.name.fl_str_mv |
Arquivos de Ciências da Saúde da UNIPAR (Online) - Universidade Paranaense (UNIPAR) |
repository.mail.fl_str_mv |
||cedic@unipar.br|| arqsaude@unipar.br |
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1800218855410237440 |