Bioequivalence and Bioavailability Forum

Thank you, Ohlbe. I appreciate the feedback.

It's nice to see the EMA weigh in on this issue, however, their decisions always seem to come down to the same tired "appropriate justification," which everyone always provides, or at least tries to provide, whenever their is a discrepancy in their study with official guidelines. This type of position, IMO, allows too much leeway for interpretation, both for the applicant and the assessors; both in a good and bad direction. At the end of the day, no one really knows what is appropriate until one submits and finds out, which, in a roundabout way, appears to bring us all the way back to the status quo. Oh well, at least they didn't say it couldn't be justified.