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RegisterDifferent power of AUC vs. Cmax at stage I - continuation rules [Two-Stage / GS Designs]
Hi all,
I would like to raise a scenario following stage I results with Potvin C:
If, hypothetically, our results at stage I would have had good ratio, and failed to meet 94.12% CI BE criteria at stage I for both Cmax and AUC.
The power analysis would have shown results higher than 80% for AUC, and lower than 80% for Cmax. Based on Cmax, we could continue to stage II. In that case - what would be the practice for AUC? I would assume it would have been calculated also for stage II. How should this be covered in the protocol?
Would appreciate your input.
Many thanks,
Nisha
I would like to raise a scenario following stage I results with Potvin C:
If, hypothetically, our results at stage I would have had good ratio, and failed to meet 94.12% CI BE criteria at stage I for both Cmax and AUC.
The power analysis would have shown results higher than 80% for AUC, and lower than 80% for Cmax. Based on Cmax, we could continue to stage II. In that case - what would be the practice for AUC? I would assume it would have been calculated also for stage II. How should this be covered in the protocol?
Would appreciate your input.
Many thanks,
Nisha
Complete thread:
- Different power of AUC vs. Cmax at stage I - continuation rulesNisha 2015-09-17 13:28 [Two-Stage / GS Designs]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Different power of AUC vs. Cmax at stage I - continuation rules ElMaestro 2015-09-17 13:56
- Different power of AUC vs. Cmax at stage I - continuation rules Nisha 2015-09-17 20:27
- AUC vs. Cmax ElMaestro 2015-09-17 21:53
- Assumption Helmut 2015-09-18 00:15
- Different power of AUC vs. Cmax at stage I - continuation rules Nisha 2015-09-17 20:27
- Different power of AUC vs. Cmax at stage I - continuation rules ElMaestro 2015-09-17 13:56
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