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Evaluation of the physicochemical and biological stability of reconstituted and diluted SB2 (infliximab)

OBJECTIVES: To evaluate the critical quality attributes that might affect the stability of an infliximab biosimilar (SB2, Flixabi) when reconstituted or diluted and stored under refrigeration and at room temperature. METHODS: We largely adhered to the UK's National Health Service guidance requi...

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Detalles Bibliográficos
Autores principales: Kim, Jihyun, Chung, Jihyun, Park, Sujin, Jung, Saem, Kang, Dukwon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5931250/
https://www.ncbi.nlm.nih.gov/pubmed/29732144
http://dx.doi.org/10.1136/ejhpharm-2016-001085