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The following message was posted to: PharmPK
Hi,
Is is acceptable to exclude 2 points from the calibration curve so
that we it paasses the accepatance criteria. i.e. more points are
passing and the total number of points is still more than 5 non zero,
and not more than 2 points are failing from a total of 7 non zero.
i.e. including these 2 points 4 points will fail and the run is
rejected.
thanks
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Hi,
You can remove the 2 failing standards from the calibration curve,
Guidelines says that a total 75% of the non zero calibration standards
should be included in the calibration curve for the acceptance of the
same.
Hope this will help you
Regards
RajaReddy Kallem
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The following message was posted to: PharmPK
Alternatively you could leave the failed points in. The guidance does
not
indicate they need be removed.
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