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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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Autors principals: Gervais, David, Corn, Tim, Downer, Andrew, Smith, Stuart, Jennings, Alan
Format: Artigo
Idioma:Inglês
Publicat: Springer US 2014
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Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC4070265/
https://ncbi.nlm.nih.gov/pubmed/24854894
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-014-9612-9
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