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Registerresidual area < 20% for more than 80% subjects [Regulatives / Guidelines]
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
» 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,
Mittyri
Kind regards,
Mittyri
Complete thread:
- Handling large Extrapolated AUC Values Sereng 2022-05-12 17:17 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- residual area < 20% for more than 80% subjectsmittyri 2022-05-14 22:06
- residual area < 20% for more than 80% subjects Sereng 2022-05-18 05:59
- Exclusion for the FDA? Helmut 2022-05-23 11:43
- residual area < 20% for more than 80% subjectsmittyri 2022-05-14 22:06
Ing. Helmut Schütz