ANALYSIS AND RELEVANCE OF DATA ABOUT ADDITIONAL STABILITY OF NIVESTIM™ ( FILGRASTIM SOLUTION FOR INJECTION )

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 batche...

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Main Author: António Melo Gouveia
Format: Article
Language:English
Published: Formifarma, LDA. 2012-06-01
Series:Revista Portuguesa de Farmacoterapia
Subjects:
Online Access:http://farmacoterapia.pt/index.php/rpf/article/view/70
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author António Melo Gouveia
author_facet António Melo Gouveia
author_sort António Melo Gouveia
collection DOAJ
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 of this 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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spelling doaj.art-512a4c23ecbc42a18a9e20616abbe9022023-08-31T22:40:42ZengFormifarma, LDA.Revista Portuguesa de Farmacoterapia1647-354X2183-73412012-06-014210.25756/rpf.v4i2.70ANALYSIS AND RELEVANCE OF DATA ABOUT ADDITIONAL STABILITY OF NIVESTIM™ ( FILGRASTIM SOLUTION FOR INJECTION )António Melo Gouveia 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 of this study. This data allows a drug product more adapted to real life use, with advantages for both patients and healthcare professionals. http://farmacoterapia.pt/index.php/rpf/article/view/70BiossimilarstabilityNivestim
spellingShingle António Melo Gouveia
ANALYSIS AND RELEVANCE OF DATA ABOUT ADDITIONAL STABILITY OF NIVESTIM™ ( FILGRASTIM SOLUTION FOR INJECTION )
Revista Portuguesa de Farmacoterapia
Biossimilar
stability
Nivestim
title 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_short 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
topic Biossimilar
stability
Nivestim
url http://farmacoterapia.pt/index.php/rpf/article/view/70
work_keys_str_mv AT antoniomelogouveia analysisandrelevanceofdataaboutadditionalstabilityofnivestimfilgrastimsolutionforinjection