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Dear Ritesh Korat,
Why wait till 20 %, if it is already visible after 2-3 runs that the concentrations are lower than expected ?
Why 67 % ? Where did you take that figure from ?
IMHO what's important is not just how many subjects have a Cmax below the MQC sample - but also how much below it is.
Or adjust the concentration of the existing MQC. The guidelines also gives this option.
❝ Firstly monitor around 20% of first subject of the study.
Why wait till 20 %, if it is already visible after 2-3 runs that the concentrations are lower than expected ?
❝ if Cmax of both period in 14 (67% of 20) subjects out of that 20 subjects cross two QC level than no need of additional QC
Why 67 % ? Where did you take that figure from ?
IMHO what's important is not just how many subjects have a Cmax below the MQC sample - but also how much below it is.
❝ and if its not than add one more QC between LQC and MQC.
Or adjust the concentration of the existing MQC. The guidelines also gives this option.
—
Regards
Ohlbe
Regards
Ohlbe
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