As per USFDA guidelines for Bioanalytical Method validation for human studies, one of the acceptance criteria for linearity is that four out of six non zero standards meet the criteria of <= 20 % deviation at LOQ and <= 15 % deviation at other concentrations. Thus if one of the level which does not meet the above criteria, should be omitted for the calculation of regression line ?
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By SOL on Friday, July 20, 2001 - 03:23 am:
If I understand you correctly then the answer is: Yes
If you start off with 6 calibration samples and one of those calibration samples fails the above criteria then the regression line should be re-calculated using the remaining 5 calibration samples.
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