about variation in CC [Bioanalytics]

posted by pmgjoshi  – India, 2009-06-28 13:17 (6184 d 16:31 ago) – Posting: # 3912
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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

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