residual area < 20% for more than 80% subjects [Regulatives / Guidelines]

posted by mittyri – Russia, 2022-05-15 00:06 (199 d 08:09 ago) – Posting: # 22986
Views: 607

Hi Sereng,

❝ 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

Kind regards,

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