Bioequivalence and Bioavailability Forum

Hello Pash413,

❝ Is there any regulatory concern if we have not included the drop out subject(s) due to ambulatory missing samples in the statastical analysis.

as I see it there is not necessarily a need to exclude a subject just because some values are missing; there may be a need for some deeree of exclusion if the data do not add to your understanding of comparative PK (/safety/efficacy). If you do not have an SOP in place then I think you could do a primary analysis on those subjects for which you have adequate characterisation however many blood samples are missing. NCA is per se not ruined by missing values. Typically missing values are in the ambulatory (and thus terminal) phase, so it would sometimes mean you can do AUCtlast, but not AUCinf.
At the end of the day if this dossier is submitted in EU or US you can be quite sure that someone will check one way or another if the ones you chose to exclude seemed to affect the conclusion of BE in the subjective way you excluded them. So whatever you do, exclude or include on basis of something very objective with zero regard to the outcome, or you could get flagged and flogged.
Excluding data is always a regulatory concern for principal reasons.