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ICH Q2(R2) Validation of analytical procedures - Scientific …
WebAn SEC method was developed to quantify antibody purity through size distribution. During method development, the method parameters were optimized based on the … Web• Method description – this section should contain a full description of the analytical method. The ... 1.3 PARAMETERS FOR METHOD VALIDATION To be fit for the intended purpose, the method must meet certain validation characteristics. Typical validation characteristics, which should be considered are: selectivity (specificity), linearity ... mavis oxford
Accuracy Validation of Size-Exclusion Chromatography
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