Pharmacologic surveillance and safety evaluation of new drugs.

Detalhes bibliográficos
Autor(a) principal: Reys, L L
Data de Publicação: 1991
Tipo de documento: Artigo
Idioma: por
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3341
Resumo: Efficacy and safety evaluation are the main objectives of clinical trials. Through a rigorous scientific methodology they compare the efficacy of the new drugs with that of standard drugs or placebo. However the design of clinical trials in phase III is more centered in the study of efficacy than in its safety. Other reason, apart this, is a natural consequence of the low number of patients recruited for this phase when the incidence of most type B adverse drug reactions is usually of the order of 1:10(-4). Therefore it is the author's contention that post-marketing (phase IV) trials and surveillance should become commoner practices since they can contribute for a permanent evaluation of drugs safety after their approval and introduction in the market.
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spelling Pharmacologic surveillance and safety evaluation of new drugs.Farmacovigilância e avaliação da segurança dos novos medicamentos.Efficacy and safety evaluation are the main objectives of clinical trials. Through a rigorous scientific methodology they compare the efficacy of the new drugs with that of standard drugs or placebo. However the design of clinical trials in phase III is more centered in the study of efficacy than in its safety. Other reason, apart this, is a natural consequence of the low number of patients recruited for this phase when the incidence of most type B adverse drug reactions is usually of the order of 1:10(-4). Therefore it is the author's contention that post-marketing (phase IV) trials and surveillance should become commoner practices since they can contribute for a permanent evaluation of drugs safety after their approval and introduction in the market.Efficacy and safety evaluation are the main objectives of clinical trials. Through a rigorous scientific methodology they compare the efficacy of the new drugs with that of standard drugs or placebo. However the design of clinical trials in phase III is more centered in the study of efficacy than in its safety. Other reason, apart this, is a natural consequence of the low number of patients recruited for this phase when the incidence of most type B adverse drug reactions is usually of the order of 1:10(-4). Therefore it is the author's contention that post-marketing (phase IV) trials and surveillance should become commoner practices since they can contribute for a permanent evaluation of drugs safety after their approval and introduction in the market.Ordem dos Médicos1991-06-30info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttps://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3341oai:ojs.www.actamedicaportuguesa.com:article/3341Acta Médica Portuguesa; Vol. 4 No. 3 (1991): Maio-Junho; 141-6Acta Médica Portuguesa; Vol. 4 N.º 3 (1991): Maio-Junho; 141-61646-07580870-399Xreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAPporhttps://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3341https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3341/2667Reys, L Linfo:eu-repo/semantics/openAccess2022-12-20T11:02:06Zoai:ojs.www.actamedicaportuguesa.com:article/3341Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T16:18:18.914305Repositório 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 Pharmacologic surveillance and safety evaluation of new drugs.
Farmacovigilância e avaliação da segurança dos novos medicamentos.
title Pharmacologic surveillance and safety evaluation of new drugs.
spellingShingle Pharmacologic surveillance and safety evaluation of new drugs.
Reys, L L
title_short Pharmacologic surveillance and safety evaluation of new drugs.
title_full Pharmacologic surveillance and safety evaluation of new drugs.
title_fullStr Pharmacologic surveillance and safety evaluation of new drugs.
title_full_unstemmed Pharmacologic surveillance and safety evaluation of new drugs.
title_sort Pharmacologic surveillance and safety evaluation of new drugs.
author Reys, L L
author_facet Reys, L L
author_role author
dc.contributor.author.fl_str_mv Reys, L L
description Efficacy and safety evaluation are the main objectives of clinical trials. Through a rigorous scientific methodology they compare the efficacy of the new drugs with that of standard drugs or placebo. However the design of clinical trials in phase III is more centered in the study of efficacy than in its safety. Other reason, apart this, is a natural consequence of the low number of patients recruited for this phase when the incidence of most type B adverse drug reactions is usually of the order of 1:10(-4). Therefore it is the author's contention that post-marketing (phase IV) trials and surveillance should become commoner practices since they can contribute for a permanent evaluation of drugs safety after their approval and introduction in the market.
publishDate 1991
dc.date.none.fl_str_mv 1991-06-30
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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dc.identifier.uri.fl_str_mv https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3341
oai:ojs.www.actamedicaportuguesa.com:article/3341
url https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3341
identifier_str_mv oai:ojs.www.actamedicaportuguesa.com:article/3341
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3341
https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/3341/2667
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
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dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Ordem dos Médicos
publisher.none.fl_str_mv Ordem dos Médicos
dc.source.none.fl_str_mv Acta Médica Portuguesa; Vol. 4 No. 3 (1991): Maio-Junho; 141-6
Acta Médica Portuguesa; Vol. 4 N.º 3 (1991): Maio-Junho; 141-6
1646-0758
0870-399X
reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
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