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RegisterFailed AUC 0-t [Study Assessment]
Dear all,
I have received the results of a pilot study of an IR product.
N=20
90% CI for Cmax is within the BE criteria. However, the upper value of the 90% CI for the AUC 0 to t is 135!. The ISV for AUC 0 to t is 24%.
My questions are:
Edit: Category changed. [Helmut]
I have received the results of a pilot study of an IR product.
N=20
90% CI for Cmax is within the BE criteria. However, the upper value of the 90% CI for the AUC 0 to t is 135!. The ISV for AUC 0 to t is 24%.
My questions are:
- If it were to be a product issue, would not both parameters be affected?
- What are the causes for having only failing AUC 0-t?
- Would increasing sample size (based on variability) to 28 be sufficient to counter the ISV of AUC 0-t?
Edit: Category changed. [Helmut]
Complete thread:
- Failed AUC 0-tTina 2013-08-29 09:25 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Failed AUC 0-t Dr_Dan 2013-08-29 11:04
- Failed AUC 0-t Tina 2013-08-29 13:11
- bear for replicates Helmut 2013-08-29 14:33
- Failed AUC 0-t Helmut 2013-08-29 13:58
- Failed AUC 0-t Tina 2013-08-29 17:48
- Correct numbers? Helmut 2013-08-29 18:24
- Failed AUC 0-t Tina 2013-08-29 17:48
- Failed AUC 0-t luvblooms 2013-08-30 09:23
- Failed AUC 0-t Dr_Dan 2013-08-29 11:04
Ing. Helmut Schütz