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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...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer US
2012
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3497960/ https://www.ncbi.nlm.nih.gov/pubmed/22893253 http://dx.doi.org/10.1007/s11095-012-0836-z |