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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...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Springer US
2014
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| 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 |