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RegisterBorderline BE study Failure [Study Assessment]
Dear All,
For Product X (IR tablets), full replicated BE study was performed on 56 volunteers under fasting state (EU submission).
When data for first half subjects (N: 28) was analysed, we got following results.
Cmax ratio: 87 (CI: 80.88-95.13)
AUC ratio: 87 (CI: 81.85-94.18)
Analysis of full data set (N: 56)
Cmax ratio: 84.32 (CI: 79.89-89.00)
AUC ratio: 86.9 (CI: 83.02-90.96)
%ISCV Cmax: 25
%ISCV AUC: 20
Power ~100
No outlier detected.
Is there any possibility to get through by any means or study to be repeated?
Or we should go ahead with the reformulation??
PROC GLM is used for stat calculation
Kindly advice.
Thanks!
Regards,
Samaya.
Edit: Category changed. [Helmut]
For Product X (IR tablets), full replicated BE study was performed on 56 volunteers under fasting state (EU submission).
When data for first half subjects (N: 28) was analysed, we got following results.
Cmax ratio: 87 (CI: 80.88-95.13)
AUC ratio: 87 (CI: 81.85-94.18)
Analysis of full data set (N: 56)
Cmax ratio: 84.32 (CI: 79.89-89.00)
AUC ratio: 86.9 (CI: 83.02-90.96)
%ISCV Cmax: 25
%ISCV AUC: 20
Power ~100
No outlier detected.
Is there any possibility to get through by any means or study to be repeated?
Or we should go ahead with the reformulation??
PROC GLM is used for stat calculation
Kindly advice.
Thanks!
Regards,
Samaya.
Edit: Category changed. [Helmut]
Complete thread:
- Borderline BE study FailureSamaya B 2014-10-14 09:02
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Borderline BE study Failure luvblooms 2014-10-14 11:03
- Borderline BE study Failure jag009 2014-10-14 16:59
- Interim analysis Ohlbe 2014-10-14 23:53
- Borderline BE study Failure Helmut 2014-10-15 15:29
Ing. Helmut Schütz