Back to the Top
I have two questions regarding bioanalytical guidelines (FROM SHAH 2000)
1- ''Usual acceptance criteria for QC are at least 67% of the QC samples
within 15%''. Does anyone use additional criteria; as exemple if the
two QCs are low (-20 and -30%, respectively) showing a drift at the end
the run, the samples between these two QCs are re-assayed?
2- ''Standard curve acceptance criteria are that 75%, or a minimum of 6
standards should fall within 15%..''.Does that mean that a standard
curve is accepted with (in any cases) at least 6 standards in the 15%
Does that also mean that if more than 6 standards are analyzed, 75%
accepted (with always a minimum of 6 in the 15 % range?) or does that
mean that a standard curve containing 6 standards could be accepted
(i.e.: 5 standards) are in the 15% range?
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "Bioanalytical guidelines acceptance criteria" as the subject
Support PharmPK by using the
Copyright 1995-2011 David W. A. Bourne (firstname.lastname@example.org)