ANALYSIS AND RELEVANCE OF DATA ABOUT ADDITIONAL STABILITY OF NIVESTIM™ ( FILGRASTIM SOLUTION FOR INJECTION )
Autor(a) principal: | |
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Data de Publicação: | 2012 |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | https://doi.org/10.25756/rpf.v4i2.70 |
Resumo: | The most recent data about stability of fligrastim biossimilar (“Nivestim™), as made available by the marketing authorization holder, is analyzed with a focus on different storage conditions and impact on real life use, both for patients and healthcare professionals. Data assessed is about 3 batches and 2 strengths of the Nivestim ™, which were studied 8 months after end of approved shelf-life. The drug product was stored at 25ºC+-2ºC for 7 days, with and without light exposure. Freeze – thaw studies were also performed. As a control, samples were kept in storage conditions as stated on the approved summary of product characteristics. The parameters analyzed were stable with no appreciable trends during the time and in the conditions ofthis study. This data allows a drug product more adapted to real life use, with advantages for both patients and healthcare professionals. |
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ANALYSIS AND RELEVANCE OF DATA ABOUT ADDITIONAL STABILITY OF NIVESTIM™ ( FILGRASTIM SOLUTION FOR INJECTION )ANÁLISE E RELEVÂNCIA DOS DADOS DE ESTABILIDADE ADICIONAIS DO NIVESTIM™ (FILGRASTIM SOLUÇÃO INJETÁVEL)The most recent data about stability of fligrastim biossimilar (“Nivestim™), as made available by the marketing authorization holder, is analyzed with a focus on different storage conditions and impact on real life use, both for patients and healthcare professionals. Data assessed is about 3 batches and 2 strengths of the Nivestim ™, which were studied 8 months after end of approved shelf-life. The drug product was stored at 25ºC+-2ºC for 7 days, with and without light exposure. Freeze – thaw studies were also performed. As a control, samples were kept in storage conditions as stated on the approved summary of product characteristics. The parameters analyzed were stable with no appreciable trends during the time and in the conditions ofthis study. This data allows a drug product more adapted to real life use, with advantages for both patients and healthcare professionals.Pretende-se com este artigo analisar os dados mais recentes, disponibilizados pelo titular da autorização de introdução no mercado (AIM), sobre a estabilidade do medicamento nas diversas condições recomendadas para o seu armazenamento (particularmente sem refrigeração) e comentar a sua relevância para os doentes e os profissionais de saúde.Os dados analisados referem-se a três lotes de duas apresentações do medicamento Nivestim™ que foram estudados oito meses após a conclusão do prazo de validade. Os estudos incidiram sobre o produto mantido em condições normais ICH para estudos em tempo real (25°C + -2°C durante sete dias), com alternância de exposição à luz. Foram igualmente estudados em condições congelamento. Para controlo utilizaram-se amostras mantidas nas condições expressas no resumo das características do medicamento (RCM), ou seja, entre 2 e 8°C.Os parâmetros estudados em todas as condições mantiveram-se estáveis e dentro das especificações definidas. Os dados apresentados, que sustentam o ponto 6.4 do RCM, apontam para uma adaptação do medicamento às condições reais de utilização, o que é vantajoso para doentes e profissionais de saúde.Formifarma2012-06-25info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttps://doi.org/10.25756/rpf.v4i2.70https://doi.org/10.25756/rpf.v4i2.70Revista Portuguesa de Farmacoterapia / Portuguese Journal of Pharmacotherapy; Vol 4 No 2 (2012): Abril; 20-24Revista Portuguesa de Farmacoterapia; v. 4 n. 2 (2012): Abril; 20-242183-73411647-354Xreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAPporhttp://revista.farmacoterapia.pt/index.php/rpf/article/view/70http://revista.farmacoterapia.pt/index.php/rpf/article/view/70/55Direitos de Autor (c) 2017 Revista Portuguesa de Farmacoterapiahttp://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessMelo Gouveia, António2023-09-01T04:33:15Zoai:ojs.farmacoterapia.pt:article/70Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T15:11:32.538815Repositório 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 |
ANALYSIS AND RELEVANCE OF DATA ABOUT ADDITIONAL STABILITY OF NIVESTIM™ ( FILGRASTIM SOLUTION FOR INJECTION ) ANÁLISE E RELEVÂNCIA DOS DADOS DE ESTABILIDADE ADICIONAIS DO NIVESTIM™ (FILGRASTIM SOLUÇÃO INJETÁVEL) |
title |
ANALYSIS AND RELEVANCE OF DATA ABOUT ADDITIONAL STABILITY OF NIVESTIM™ ( FILGRASTIM SOLUTION FOR INJECTION ) |
spellingShingle |
ANALYSIS AND RELEVANCE OF DATA ABOUT ADDITIONAL STABILITY OF NIVESTIM™ ( FILGRASTIM SOLUTION FOR INJECTION ) Melo Gouveia, António |
title_short |
ANALYSIS AND RELEVANCE OF DATA ABOUT ADDITIONAL STABILITY OF NIVESTIM™ ( FILGRASTIM SOLUTION FOR INJECTION ) |
title_full |
ANALYSIS AND RELEVANCE OF DATA ABOUT ADDITIONAL STABILITY OF NIVESTIM™ ( FILGRASTIM SOLUTION FOR INJECTION ) |
title_fullStr |
ANALYSIS AND RELEVANCE OF DATA ABOUT ADDITIONAL STABILITY OF NIVESTIM™ ( FILGRASTIM SOLUTION FOR INJECTION ) |
title_full_unstemmed |
ANALYSIS AND RELEVANCE OF DATA ABOUT ADDITIONAL STABILITY OF NIVESTIM™ ( FILGRASTIM SOLUTION FOR INJECTION ) |
title_sort |
ANALYSIS AND RELEVANCE OF DATA ABOUT ADDITIONAL STABILITY OF NIVESTIM™ ( FILGRASTIM SOLUTION FOR INJECTION ) |
author |
Melo Gouveia, António |
author_facet |
Melo Gouveia, António |
author_role |
author |
dc.contributor.author.fl_str_mv |
Melo Gouveia, António |
description |
The most recent data about stability of fligrastim biossimilar (“Nivestim™), as made available by the marketing authorization holder, is analyzed with a focus on different storage conditions and impact on real life use, both for patients and healthcare professionals. Data assessed is about 3 batches and 2 strengths of the Nivestim ™, which were studied 8 months after end of approved shelf-life. The drug product was stored at 25ºC+-2ºC for 7 days, with and without light exposure. Freeze – thaw studies were also performed. As a control, samples were kept in storage conditions as stated on the approved summary of product characteristics. The parameters analyzed were stable with no appreciable trends during the time and in the conditions ofthis study. This data allows a drug product more adapted to real life use, with advantages for both patients and healthcare professionals. |
publishDate |
2012 |
dc.date.none.fl_str_mv |
2012-06-25 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://doi.org/10.25756/rpf.v4i2.70 https://doi.org/10.25756/rpf.v4i2.70 |
url |
https://doi.org/10.25756/rpf.v4i2.70 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
http://revista.farmacoterapia.pt/index.php/rpf/article/view/70 http://revista.farmacoterapia.pt/index.php/rpf/article/view/70/55 |
dc.rights.driver.fl_str_mv |
Direitos de Autor (c) 2017 Revista Portuguesa de Farmacoterapia http://creativecommons.org/licenses/by-nc-nd/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Direitos de Autor (c) 2017 Revista Portuguesa de Farmacoterapia http://creativecommons.org/licenses/by-nc-nd/4.0 |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Formifarma |
publisher.none.fl_str_mv |
Formifarma |
dc.source.none.fl_str_mv |
Revista Portuguesa de Farmacoterapia / Portuguese Journal of Pharmacotherapy; Vol 4 No 2 (2012): Abril; 20-24 Revista Portuguesa de Farmacoterapia; v. 4 n. 2 (2012): Abril; 20-24 2183-7341 1647-354X reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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RCAAP |
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RCAAP |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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