Bioequivalence and Bioavailability Forum

Dear BE-proff,

❝ So, it to sum up - single missed administrations can hardly influence seriously on PK-results. Correct?

No, that is not what I meant.
Single missed administrations can badly screw up everything. But they don't necessarily do so. It all comes down to ADME properties and stochastics and everything.
Clearly missed administration have the potential to depress 'apparent' SS profiles. But in BE we are looking at GMR's; if the missed doses happened at random then even though individual profiles are screwed up badly there is still a chance that the study outcome is positive.

I think I will propose this:
Let GMR be the true ratio. Let GMR' be the observed geometric mean ratio in case of no missed doses. Let GMR'' be the observed geometric mean ratio when missed doses happen. Provided the missed doses happen at random I would think that these quantities can be expected to be the same (in spite of the fact that in case of missed doses some PK-profiles may be a lot different from what they'd look like without missed doses).

All hope is therefore not lost. I hope you see what I mean.
Желаю хорошо провести выходные.