Bioanalytical chromatographic method validation according to current regulations, with a special focus on the non-well defined parameters limit of quantification, robustness and matrix effect.
作者： Oskar González , María Encarnación Blanco , Gorka Iriarte , Luis Bartolomé , Miren Itxaso Maguregui
DOI: 10.1016/J.CHROMA.2014.03.077
关键词: Process (engineering) 、 Stability (learning theory) 、 Well-defined 、 Robustness (economics) 、 Chemistry 、 Bioanalysis 、 Focus (optics) 、 Range (mathematics) 、 Chromatography
摘要: … Although the ICH guideline Q8 (R2) either does not explicitly discuss analytical method development, the QbD concept can be extended and results in a systematic approach that …
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