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Dear all,
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
last
two QCs are low (-20 and -30%, respectively) showing a drift at the end
of
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% range? Does
that also mean that if more than 6 standards are analyzed, 75% should be
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 if 75%
(i.e.:
5 standards) are in the 15% range?
Thank you very much for your answer
Henri BENECH
Service de Pharmacologie et d'Immunologie
CEA/Saclay, FRANCE
91191 Gif-Sur-Yvette Cedex
henri.benech.-at-.cea.fr
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Hi there
The guidelines for Calibration curve says that either minimum 6 points,
which is also 75% of total 8 point calibration curve also or 75% of the
total number of CC points should be within 15% acceptance limit for
calibration curve . Incase if you are taking 10 point calibration curve
then minimum 6 points should be there within 15% (which is not 75% of
the
total points).
Thanks
Ashish Jain, M.Pharm.
Head-Bioanalytics
Wellquest
Wellspring Hospital (6th Floor)
Ganpatrao Kadam Marg,
Off Worli Naka,
Lower Parel,
Mumbai - 400 013
Email: rjain.-a-.nicholaspiramal.co.in
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