Bioequivalence and Bioavailability Forum

Hello everyone,

We conducted an isotretinoin BE study way back yonder when the current guideline was merely a twinkle in a reform-minded regulator's eye (meaning, it was more than a couple years ago). We recently submitted this study as part of an MAA.

The study was conducted with a "light breakfast" when the current climate requires a delicious high-fat, high-calorie meal (hey, I'm a big fan of bacon and eggs). We've been called on this in a deficiency letter. I understand that it is super easy for the regulator to dismiss any justification we might come up with, however the deficiency is worded in a way that suggests they are willing to be convinced to "look the other way" (It should therefore be justified that the bioequivalence study results can be extrapolated to other types of meals). We are willing to test their apparent good will.

I'm putting something together about standardisation of studies, etc, as we speak.

So, my questions to you all is the following: what justification would you put together to convince the regulator to look the other way on the inadequate breakfast (about 450 kcal and 42% fat)?

Thank you,
Torn