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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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| Hlavní autoři: | , , , , |
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| Médium: | Artigo |
| Jazyk: | Inglês |
| Vydáno: |
Springer US
2014
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| Témata: | |
| On-line přístup: | 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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