Bioequivalence and Bioavailability Forum

Dear Mittyri,

❝ What kind of excluding rule do you prefer in SAP for such cases?

❝ "The obtained samples with the time devitaions more than 5% of the current length of sampling time should be excluded from descriptive statistics"

❝ Could this rule be used?

It could.

However, the acceptance rule should be adapted to the expected PK profile (and from your sampling schedule ).
For instance, if you are sampling in a phase with an apparent half-life of 8 h: taking a sample 10% before the planned time will result in a bias of less than 1%… no real concern here !
However, if you are in a phase with an apparent half-life of 15 min (quick distribution phase for instance), taking a sample 10% too early would result in a bias > 30%… more difficult to justify keeping the concentration in descriptive statistics .
In this case, the time deviation should be kept <3% to limit the bias <10%.

So all of this is about finding a good (not saying "the best") compromise that could work for most of the expected individual PK profiles (considering the inter-individual variability).