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RegisterHandling large Extrapolated AUC Values [Regulatives / Guidelines]
Dear Colleagues, 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? Regards,
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Biostatistically Challenged CEO
Biostatistically Challenged CEO
Complete thread:
- Handling large Extrapolated AUC ValuesSereng 2022-05-12 17:17 [Regulatives / Guidelines]
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- residual area < 20% for more than 80% subjects mittyri 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% subjects mittyri 2022-05-14 22:06
Ing. Helmut Schütz