Production of a pharmacokinetic and bioequivalence analysis module in SAS

Detalhes bibliográficos
Autor(a) principal: Rodrigues, Vítor Hugo Chaves
Data de Publicação: 2024
Tipo de documento: Dissertação
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10773/42761
Resumo: This internship report describes the activities carried out during the curricular internship at BlueClinical, An Astrum Company, in the role of biostatistician, as part of the Master’s Degree in Medical Statistics at the University of Aveiro. It focused on Biostatistics and Data Programming tasks in clinical trials, with the aim of developing the knowledge acquired throughout my academic career, as well as its consolidation and applicability in the practical context of professional activity in the Pharmaceutical industry and Clinical Trials. The report presents a description of the Host Entity, followed by a brief description of the fundamental aspects of Clinical Trials. It then describes all the activities carried out during the internship, from revising Statistical Analysis Plans (SAPs) to standardizing the data to be included in the tables of the study report. The internship encompassed a component that included skills in the area of pharmacokinetics, which are explored in this report and applied through SAS programming. This internship allowed me to develop and consolidate skills in the areas of Biostatistics, Clinical Data Programming and Pharmacokinetics, which are essential for my professional future.
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spelling Production of a pharmacokinetic and bioequivalence analysis module in SASClinical trialsBioequivalence trialsBiostatisticsClinical data programmingSASTFLsPharmacokinetic analysisBioequivalence analysisThis internship report describes the activities carried out during the curricular internship at BlueClinical, An Astrum Company, in the role of biostatistician, as part of the Master’s Degree in Medical Statistics at the University of Aveiro. It focused on Biostatistics and Data Programming tasks in clinical trials, with the aim of developing the knowledge acquired throughout my academic career, as well as its consolidation and applicability in the practical context of professional activity in the Pharmaceutical industry and Clinical Trials. The report presents a description of the Host Entity, followed by a brief description of the fundamental aspects of Clinical Trials. It then describes all the activities carried out during the internship, from revising Statistical Analysis Plans (SAPs) to standardizing the data to be included in the tables of the study report. The internship encompassed a component that included skills in the area of pharmacokinetics, which are explored in this report and applied through SAS programming. This internship allowed me to develop and consolidate skills in the areas of Biostatistics, Clinical Data Programming and Pharmacokinetics, which are essential for my professional future.O presente relatório de estágio descreve as atividades realizadas durante o estágio curricular na BlueClinical, An Astrum Company, na função de bioestatístico, no âmbito do Mestrado em Estatística Médica da Universidade de Aveiro. Este focou-se em tarefas de Bioestatística e Programação de Dados em ensaios clínicos, tendo como objetivo o desenvolvimento dos conhecimentos adquiridos ao longo do meu percurso académico, bem como a sua consolidação e aplicabilidade no contexto prático de atividade profissional na área da indústria Farmacêutica e Ensaios Clínicos. O relatório apresenta uma descrição da Entidade de Acolhimento, seguida de uma breve descrição dos aspetos fundamentais dos Ensaios Clínicos. Em seguida, são descritas todas as atividades desenvolvidas ao longo do estágio, desde revisões de Statistical Analysis Plans (SAPs), até à padronização dos dados para serem incluídos nas tabelas do relatório do estudo. O estágio englobou uma componente que incluiu competências na área da farmacocinética as quais são exploradas neste relatório e aplicadas através de programação SAS. Este estágio permitiu-me desenvolver e consolidar competências na área de Bioestatística, Programação de Dados Clínicos e Farmacocinética, essenciais para o meu futuro profissional.2026-07-19T00:00:00Z2024-07-09T00:00:00Z2024-07-09info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisapplication/pdfhttp://hdl.handle.net/10773/42761engRodrigues, Vítor Hugo Chavesinfo:eu-repo/semantics/embargoedAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-11-11T01:47:46Zoai:ria.ua.pt:10773/42761Portal AgregadorONGhttps://www.rcaap.pt/oai/openairemluisa.alvim@gmail.comopendoar:71602024-11-11T01:47:46Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Production of a pharmacokinetic and bioequivalence analysis module in SAS
title Production of a pharmacokinetic and bioequivalence analysis module in SAS
spellingShingle Production of a pharmacokinetic and bioequivalence analysis module in SAS
Rodrigues, Vítor Hugo Chaves
Clinical trials
Bioequivalence trials
Biostatistics
Clinical data programming
SAS
TFLs
Pharmacokinetic analysis
Bioequivalence analysis
title_short Production of a pharmacokinetic and bioequivalence analysis module in SAS
title_full Production of a pharmacokinetic and bioequivalence analysis module in SAS
title_fullStr Production of a pharmacokinetic and bioequivalence analysis module in SAS
title_full_unstemmed Production of a pharmacokinetic and bioequivalence analysis module in SAS
title_sort Production of a pharmacokinetic and bioequivalence analysis module in SAS
author Rodrigues, Vítor Hugo Chaves
author_facet Rodrigues, Vítor Hugo Chaves
author_role author
dc.contributor.author.fl_str_mv Rodrigues, Vítor Hugo Chaves
dc.subject.por.fl_str_mv Clinical trials
Bioequivalence trials
Biostatistics
Clinical data programming
SAS
TFLs
Pharmacokinetic analysis
Bioequivalence analysis
topic Clinical trials
Bioequivalence trials
Biostatistics
Clinical data programming
SAS
TFLs
Pharmacokinetic analysis
Bioequivalence analysis
description This internship report describes the activities carried out during the curricular internship at BlueClinical, An Astrum Company, in the role of biostatistician, as part of the Master’s Degree in Medical Statistics at the University of Aveiro. It focused on Biostatistics and Data Programming tasks in clinical trials, with the aim of developing the knowledge acquired throughout my academic career, as well as its consolidation and applicability in the practical context of professional activity in the Pharmaceutical industry and Clinical Trials. The report presents a description of the Host Entity, followed by a brief description of the fundamental aspects of Clinical Trials. It then describes all the activities carried out during the internship, from revising Statistical Analysis Plans (SAPs) to standardizing the data to be included in the tables of the study report. The internship encompassed a component that included skills in the area of pharmacokinetics, which are explored in this report and applied through SAS programming. This internship allowed me to develop and consolidate skills in the areas of Biostatistics, Clinical Data Programming and Pharmacokinetics, which are essential for my professional future.
publishDate 2024
dc.date.none.fl_str_mv 2024-07-09T00:00:00Z
2024-07-09
2026-07-19T00:00:00Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/masterThesis
format masterThesis
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10773/42761
url http://hdl.handle.net/10773/42761
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/embargoedAccess
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dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
institution RCAAP
reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
repository.mail.fl_str_mv mluisa.alvim@gmail.com
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