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RegisterScaling/Widening of AUC [Regulatives / Guidelines]
Dears
Also Regarding AUC widening, is it applicable in both partially and fully replicate designs or fully replicate design only as FDA referred to the published book chapter for RSABE for AUC and Cmax in fda draft guidance for progesterone? So could we apply it in general or it’s not applicable?
Also Regarding AUC widening, is it applicable in both partially and fully replicate designs or fully replicate design only as FDA referred to the published book chapter for RSABE for AUC and Cmax in fda draft guidance for progesterone? So could we apply it in general or it’s not applicable?
Complete thread:
- Scaling/Widening of AUC Researcher101 2021-02-23 20:40 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Scaling/Widening of AUCLoky do 2021-02-24 13:13
- Scaling/Widening of AUC Helmut 2021-02-24 15:29
- Scaling/Widening of AUC Loky do 2021-02-24 16:13
- Scaling/Widening of AUC dshah 2021-03-16 06:39
- Scaling/Widening of AUC Helmut 2021-03-16 13:55
Ing. Helmut Schütz