Bioequivalence and Bioavailability Forum

Dear HS,

Thanks for your comments and for your quick reply!!!
For sure I will take into account for the future.

Do you think we will receive comments from regulatory authorities due to that? or as long as all concentrations are below 5% of Cmax it's OK.

I have to say that I used Mean+SD reported in previous bioequivalence studies and SmPC to calculate washout, so as per your comments I shouldn't have %50 percent of subjects with pre-dose levels. On the other hand, I used a lower LLOQ, then I think pre-dose levels are due to flat part of the profile (pure elimination phase).

I think I will use data on SmPC and literature to justify this fact, hoping that it has no impact on the assessment of the application.

Thanks!!!