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RegisterInterim analysis [Study Assessment]
Dear Samaya,
Did you plan for a two-stage design (which I understand is tricky for full replicate studies) ? If so, why proceed to the second stage though BE was demonstrated ? If not, then what was the reason for doing an interim analysis ? Was it planned in the protocol (with appropriate alpha-correction) ?
❝ 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)
Did you plan for a two-stage design (which I understand is tricky for full replicate studies) ? If so, why proceed to the second stage though BE was demonstrated ? If not, then what was the reason for doing an interim analysis ? Was it planned in the protocol (with appropriate alpha-correction) ?
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Borderline BE study Failure Samaya B 2014-10-14 09:02 [Study Assessment]
![[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 analysisOhlbe 2014-10-14 23:53
- Borderline BE study Failure Helmut 2014-10-15 15:29
Ing. Helmut Schütz