Uncertainty Estimates of Purity Measurements Based on Current Information: Toward a “Live Validation” of Purity Methods

PURPOSE: To predict precision and other performance characteristics of chromatographic purity methods, which represent the most widely used form of analysis in the biopharmaceutical industry. METHODS: We have conducted a comprehensive survey of purity methods, and show that all performance character...

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Hlavní autoři: Apostol, Izydor, Kelner, Drew, Jiang, Xinzhao Grace, Huang, Gang, Wypych, Jette, Zhang, Xin, Gastwirt, Jessica, Chen, Kenneth, Fodor, Szilan, Hapuarachchi, Suminda, Meriage, Dave, Ye, Frank, Poppe, Leszek, Szpankowski, Wojciech
Médium: Artigo
Jazyk:Inglês
Vydáno: Springer US 2012
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Research Paper
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC3497960/
https://ncbi.nlm.nih.gov/pubmed/22893253
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s11095-012-0836-z
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