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Dear Elena777!
I meant decision scheme (in graph theory mathematicians call "trees" undirected graphs). See also this message.
In this situation we still have to go to the next stage. As it was shown before the fail for AUC (if it has less variability than Cmax) in the second stage is very unlikely. So it just doesn't matter what was CI for AUC after the first stage, the second stage for Cmax should be crucial.
❝ tree?
I meant decision scheme (in graph theory mathematicians call "trees" undirected graphs). See also this message.
❝ To be in compliance with method C of Potvin, we re-calculate CI for Cmax with α=0,0294. Let`s assume that BE criterion for Cmax is met after this step. Should we also re-calculate CI for AUC with α=0,0294? Otherwise, finally we will have the following in a CSR: BE criterion was met for AUC using α=0,05 (90%CI) and BE criterion was met for Cmax using α=0,0294 (94,12% CI). Does it look OK?
In this situation we still have to go to the next stage. As it was shown before the fail for AUC (if it has less variability than Cmax) in the second stage is very unlikely. So it just doesn't matter what was CI for AUC after the first stage, the second stage for Cmax should be crucial.
—
"Being in minority, even a minority of one, did not make you mad"
"Being in minority, even a minority of one, did not make you mad"
Complete thread:
- Appropriate wording for a protocol Elena777 2019-09-09 19:34 [Two-Stage / GS Designs]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Appropriate wording for a protocol ElMaestro 2019-09-09 21:39
- Appropriate wording for a protocol Helmut 2019-09-09 23:27
- Appropriate wording for a protocol Ohlbe 2019-09-10 10:27
- Which country? Helmut 2019-09-09 23:17
- Which country? Elena777 2019-09-11 20:24
- EEU-rules, TSD-methods (lengthy answer) Helmut 2019-09-12 01:31
- EEU-rules, TSD-methods (lengthy question) Astea 2019-09-14 14:56
- n2 based on PK metric with higher CV Helmut 2019-09-16 11:50
- Q&A ref Astea 2019-09-16 18:28
- The omniscient oracle has spoken Helmut 2019-09-17 12:27
- The omniscient oracle has spoken Astea 2019-09-17 20:34
- OT: Булга́ков Helmut 2019-09-18 12:12
- The omniscient oracle has spoken Astea 2019-09-17 20:34
- The omniscient oracle has spoken Helmut 2019-09-17 12:27
- n2 based on PK metric with higher CV Elena777 2019-09-16 19:48
- AUC passes with 0.05 and Cmax with 0.0294 Helmut 2019-09-16 23:30
- AUC passes with 0.05 and Cmax with 0.0294 Mikalai 2019-09-18 16:56
- Hybrid B/C Helmut 2019-09-18 17:09
- AUC passes with 0.05 and Cmax with 0.0294 Elena777 2019-09-19 08:34
- Use data of all dosed subjects Helmut 2019-09-19 15:16
- Use data of all dosed subjects Elena777 2019-09-19 15:27
- ‘Method C’ ⇒ risky Helmut 2019-09-19 16:15
- Use data of all dosed subjects Elena777 2019-09-19 15:27
- Use data of all dosed subjects Helmut 2019-09-19 15:16
- AUC passes with 0.05 and Cmax with 0.0294 Mikalai 2019-09-18 16:56
- AUC passes with 0.05 and Cmax with 0.0294 Helmut 2019-09-16 23:30
- Q&A ref Astea 2019-09-16 18:28
- EEU-rules, TSD-methods (lengthy question) Elena777 2019-09-16 19:35
- apple tree for two-stageAstea 2019-09-16 20:39
- overripe apples Helmut 2019-09-16 23:37
- override apples Astea 2019-09-17 06:14
- overripe apples Helmut 2019-09-16 23:37
- apple tree for two-stageAstea 2019-09-16 20:39
- n2 based on PK metric with higher CV Helmut 2019-09-16 11:50
- EEU-rules, TSD-methods (lengthy question) Astea 2019-09-14 14:56
- EEU-rules, TSD-methods (lengthy answer) Helmut 2019-09-12 01:31
- Which country? Elena777 2019-09-11 20:24
- Appropriate wording for a protocol ElMaestro 2019-09-09 21:39
Ing. Helmut Schütz