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1.Please clarifies whether, Statistical Outliers in the Quality
control samples cannot be taken for calculating Accuracy and
Precision. (During inter and intra day results reporting in
bioanalytical method validation). As per USFDA guidelines identify
the statistical outlier in the bioanalytical report, but it is not
applied in the calculation. Whether Same should be applied for during
study sample analysis Reporting?
2.Whether the Inter day and Intra day Accuracy and Precision tables
can be reported with and without QC outliers in the bioanalytical
report and method validation report?
Thanks and regards,
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