Bioequivalence and Bioavailability Forum

Hello guys.

Very interesting indeed, huh? We've also received that kind of feedback, it's a standard response when ANVISA is questioned about BE approaches for HVDs. From what I heard here, the first approach described by HS up here is the one that they want. Same regulatory constant.
They think that drugs with variability between 30% and 40% are not HVDs in fact, since the rate of BE approval in this range is acceptable, according to them. IMHO that affirmation is reasonable, but how would that be used together with EMA's ABEL I wouldn't know how.

For sure planning a study in those conditions is very hard. Very few people have tried scaling for ANVISA, since it's not yet very well established how it should be done.

Hope to have been of help. Best regards.

Lucas