residual area < 20% for more than 80% subjects [Regulatives / Guidelines]
❝ despite best efforts (adequate sampling duration), if you should determine that one or more subjects contributes a large extrapolated AUC (>20%) in a BE study, how should we deal with it?
that's OK if the number of subjects with large residual area is less than 20%
Otherwise the sampling duration is not adequate or there are other issues with formulation/analyte/product
PS: above is true for EMA guide and bound jurisdictions