Bioequivalence and Bioavailability Forum

Dear Members,

I have a doubt in pharmacokinetic repeats.

When last time point shows a concentration which is above limit of quantification and is higher than the previous time point even after repeating.

Which of the following values should be taken for final pharmacokinetic and statistical calculation:
1. should we drop this time point.
2. Take the original value itself
3. Take the mean of the original value and the repeat value

If we want to put some criteria to address this issue in our SOP. What should we write in the SOP.

Thanks and Regards,

Roshini Singh