ELABORATION OF GUIDELINE FOR MONITORING IN RELATIVE BIOAVAILABILITY / PHARMACEUTICAL BIOEQUIVALENCE STUDY BY THE SPONSOR
DOI:
https://doi.org/10.25110/arqsaude.v26i3.2022.8400Resumo
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.Downloads
Publicado
Como Citar
Edição
Seção
Licença
Os Direitos Autorais para artigos publicados são de direito da revista. Em virtude da aparecerem nesta revista de acesso público, os artigos são de uso gratuito, com Creative Commons Attribution 4.0 International License.
A revista se reserva o direito de efetuar, nos originais, alterações de ordem normativa, ortográfica e gramatical, com vistas a manter o padrão culto da língua e a credibilidade do veículo. Respeitará, no entanto, o estilo de escrever dos autores.
Alterações, correções ou sugestões de ordem conceitual serão encaminhadas aos autores, quando necessário. Nesses casos, os artigos, depois de adequados, deverão ser submetidos a nova apreciação.
As opiniões emitidas pelos autores dos artigos são de sua exclusiva responsabilidade.