Production of a pharmacokinetic and bioequivalence analysis module in SAS
Autor(a) principal: | |
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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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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 |
eu_rights_str_mv |
embargoedAccess |
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 |
_version_ |
1817548688971530240 |