Bioequivalence and Bioavailability Forum

Hi luvblooms,

❝ If higher variability is a constrain you can always use Weibull method or MSD. EMA accept that.

(my coloring)
Perhaps, I think those are slightly dangerous statements. Wouldn't you rather say that some assessors may accept the use of a Weibull or MSD model if you are in a sittuation where the basic discussion in 1401/98 does not pave the way forward? Technically I guess EMA won't accept anything as assessment is done at the national agencies and there is as far as I know no guidance in place which forces any national assessor to have any specific opinion about any named dissolution model other than the moderate discussion available in 1401/98.