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The following message was posted to: PharmPK
When validating a bioanalytical method, the guidance document does not
specify how many validation samples(QC'S) have to be analyzed with each
validation run.
For routine analysis it says 2 samples at each QC level but what about
during method validation?
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The following message was posted to: PharmPK
Most CRO's use six samples at each level ( 3 QCs, LLOQ and ULOQ)during
the accuracy and precision runs. During the stability experiments, this
decreases to 3 samples at each of two levels (Hi and Lo) for the
experimental samples while plate acceptance uses 3 samples at each of 3
levels
--
Ed O'Connor, Ph.D.
Laboratory Director
Matrix BioAnalytical Laboratories
25 Science Park at Yale
New Haven, CT 06511
Web: www.matrixbioanalytical.com
Email: eoconnor.-a-.matrixbioanalytical.com
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Regarding the number of QCs per run to analyze during validation, the
2001 FDA guidance indicates that precision/accuracy should be assessed
with at least 5 replicates. (Many labs use 6, so that in case one is
lost to technical problem, the remaining replicates can be used).
A typical plan is to analyze 6 replicates in each of 3 runs for each
QC concentration.
-Tom
Thomas L. Tarnowski, Ph.D.
Bioanalytical Development
Elan Pharmaceuticals, Inc.
800 Gateway Boulevard
South San Francisco, CA 94080
thomas.tarnowski.at.elan.com
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The following message was posted to: PharmPK
dear,
during the P & A batch of validation six to 9 QC may be recommended as
per usual practice of industry but again at least six sample is
exampled by FDA in the guidance.
for more accuracy you can alow the LLOQ with the set of LQC, MQC, HQC.
to pass the criteria of 67% , you can set the the QC ammont as 6 so
that 4 can be justify as 67.33%.
regards,
paresh
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