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The following message was posted to: PharmPK
Dear Group Members,
This is in regards to the method validation in bioanalytical analysis.
1. How much percentage difference in recoveries between the LQC, MQC,
HQC,s are accepted .
2. What could be the impact of the on the pharmacokinetic profiling
of drug if the recoveries varies drastically with concentrations.
please clarify.
Manoj
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The following message was posted to: PharmPK
Dear Manoj
If you mean differences in recovery of LQC and that of HQC (X% >>>> Y
%) - the answer is preferably NONE. Difference will be observed
provided there is saturation (due to any reason) occurring at LQC
itself during extraction. However, logically, such saturation
phenomenon and hence differential extraction recovery will be
observed for the calibration levels as well. I do not anticipate
there would be any cause to worry as long as there is a reproducible
technique and method.
But, I am not sure if you would get reproducible CC in this case. It
is better to work on to find out a better extraction method rather
than work around with a method giving differential extraction recovery.
with best regards
Dr.Prashant Bodhe
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The following message was posted to: PharmPK
I am assuming that you are referring to a LC/MS method. The recoveries
should not affect drastically with concentration. Usually, they are
around
20% maximum for LQC and 15% for MQC and HQC.
For a ligand binding these may change to 25% and 20%.
Binodh DeSilva
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The following message was posted to: PharmPK
Hi,
In my opinion, as long as your intra-day and inter-day
validation for precision and accuracy are good such as
with a cv% and accuracy of 15% (LOQ has to be within
20%.
I would not concern too much.
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