Bioequivalence and Bioavailability Forum

Hello dear forum members.

From a recent post in this forum in combination with a discussion yesterday, I was remembered that I always wanted to get the opinion of other people on a (probably small) issues. Mostly because there may be simple answers I am just not aware of and missed in the standard text books.

And unfortunately, most colleagues just tell me that that is interesting (thinking "who cares").

From time to time we see development projects where multiple studies were necessary/conducted and one of these studies failed unexpectedly. As an illustrative example, BE on the low and high strength was successful, the intermediate one failed (although that particular one would have been eligible for a strength waiver anyway).

From my point of view, this may simply be a misleading finding due to chance, because, staying in that example, conducting three studies at a power of 80% will result in a fifty-fifty chance to have all of them being successful (0.8^3). By implication, it might even be reasonable to "overpower" each single study in order to end with an "overall power" of 80% (0.93^3 is roughly 80%).

As said, I may completely miss the point here (and failed to use the search funtion properly) and would be grateful for correction. Although I won't reject encouragment and, generally, will appreciate any input .

Best regards,

Steven.