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Measurement of Subvisible Particulates in Lyophilised Erwinia chrysanthemil-asparaginase and Relationship with Clinical Experience

In order to generate further characterisation data for the lyophilised product Erwinia chrysanthemi l-asparaginase, reconstituted drug product (DP; marketed as Erwinase or Erwinaze) was analysed for subvisible (2–10 μm) particulate content using both the light obscuration (LO) method and the newer f...

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Detalles Bibliográficos
Autores principales: Gervais, David, Corn, Tim, Downer, Andrew, Smith, Stuart, Jennings, Alan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4070265/
https://www.ncbi.nlm.nih.gov/pubmed/24854894
http://dx.doi.org/10.1208/s12248-014-9612-9