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RegisterPartial AUC [Regulatives / Guidelines]
Hi Elena
If you want to assess partial AUC as primary parameter you need to keep in mind that the intra-subject variability of the partial AUC is different from AUCt and AUCinf and could be much higher than the intra-subject variability of Cmax. Consequently you would need much more subjects in a BE study to demonstrate equivalence i.e. the 90 CI of partial AUC within the acceptance range.
I hope this helps
Kind regards
Dan
If you want to assess partial AUC as primary parameter you need to keep in mind that the intra-subject variability of the partial AUC is different from AUCt and AUCinf and could be much higher than the intra-subject variability of Cmax. Consequently you would need much more subjects in a BE study to demonstrate equivalence i.e. the 90 CI of partial AUC within the acceptance range.
I hope this helps
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Partial AUC Elena 2013-05-21 22:07
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Partial AUC jag009 2013-05-22 15:15
- Partial AUC Elena 2013-05-22 16:19
- Partial AUC: EMA Helmut 2013-05-23 16:12
- Partial AUCDr_Dan 2013-05-24 09:50
- Partial AUC Elena 2013-05-22 16:19
- Partial AUC jag009 2013-05-22 15:15
Ing. Helmut Schütz