Bioequivalence and Bioavailability Forum

hi BE-proff,

❝ What would you write in reports except statement of deviations?

I actually would not do much, but just deal with it.
For out-patients or out-subjects you will always expect some degree of noncompliance.

Typically you have the little dispensing bags or something so that you can keep track of who missed which doses. You can easily -I assume?- get a list of protocol violators.

In BE the conservative population is the PP population and not the ITT population. So, depending on wording in your protocol, the primary analysis to submit is either done on the compliant subjects or on "everyone" for lack of better wording.
If noncompliance is not at random (say, hypothetically if T has more side effects than R, so subjects stop specifically taking T purposefully) then it is of course another matter but this would be only theoretical, I hope.

❝ Nobody can guarantee that a regulator will not reject your results saying they were obtained from deviated people

If this discussion is about deviated people (what an absolutely wonderful term!!!) then you have certainly come to the right place. In this forum they are aplenty .

I am not entirely sure the problem in your case is really, really big. It is an issue yes, but an experienced assessor should acknowledge it. Mainly I see this as potential lack of power due to exclusions. Let's hear a bit more details. This does not have to be frightening.