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Dear All
I have a query regarding repeat analysis:
In one of the subject concentration of PD+IS was more than 5% of Cmax
of that period (it's 6% to be precise). The predose was clean. But the
concentration of PD+IS was a BLQ (below limit of quantification), my
question is do we repeat this period?
Regards
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Dear Bharat,
As per my view, there is no need to repeat the sample. Since the value
is BLQ, it will be considered zero once it is fed in WinNonlin for PK
analysis and thus you don't require to calculate the percentage of
Cmax. It will be calculated only for Conc. values which are above
LLOQ. I think the problem is that your Cmax is too low.
--
With Regards,
Mohsin U.Vohra
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Dear Bharat,
First of all I would like to comment on your method development.
BLQ>5% of Cmax is really surprizing!
Anyway if your SOP says then it could be repeated irrespective ofor >BLQ.
HM
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