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Dear sir,
I want to know the basis for the following Calibration curve acceptance criteria in the guideline:
"Calibration Curve/Standard Curve/Concentration-Response
The following conditions should be met in developing a calibration curve:
#20% deviation of the LLOQ from nominal concentration
#15% deviation of standards other than LLOQ from nominal concentration"
Specifically regarding the %RSD, is there any Statistical basis for the limits ?
Why 20% at LLOQ level? and why 15% at other than LLOQ level?
Best regards,
PMGJOSHI
I want to know the basis for the following Calibration curve acceptance criteria in the guideline:
"Calibration Curve/Standard Curve/Concentration-Response
The following conditions should be met in developing a calibration curve:
#20% deviation of the LLOQ from nominal concentration
#15% deviation of standards other than LLOQ from nominal concentration"
Specifically regarding the %RSD, is there any Statistical basis for the limits ?
Why 20% at LLOQ level? and why 15% at other than LLOQ level?
Best regards,
PMGJOSHI
Complete thread:
- about variation in CCpmgjoshi 2009-06-28 11:17
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- History of validation Helmut 2009-06-28 13:30
Ing. Helmut Schütz