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RegisterAUC passes with 0.05 and Cmax with 0.0294 [Two-Stage / GS Designs]
Dear Helmut,
What prevents us from evaluating the bioequivalence at α-level of 5% as the first step, and if we pass the bioequivalence criteria, we stop the trial. If we fail, we then evaluate the power. If power is more than 80% for the failed parameter, we stop the trial and we are done. If power is less than 80% for the failed parameter, then we go the next stage and adust α-level correspondingly to preserve overall α-level at 0,5. Of course, this should be written in the protocol and is a deviation, maybe a big one, from Potvin C method.
Regards,
Mikalai
❝ 1. If interim power is <80%, your assumptions about the CV were not correct. Assess the study with the adjusted α 0.0294.
❝ a. If you pass, stop.
What prevents us from evaluating the bioequivalence at α-level of 5% as the first step, and if we pass the bioequivalence criteria, we stop the trial. If we fail, we then evaluate the power. If power is more than 80% for the failed parameter, we stop the trial and we are done. If power is less than 80% for the failed parameter, then we go the next stage and adust α-level correspondingly to preserve overall α-level at 0,5. Of course, this should be written in the protocol and is a deviation, maybe a big one, from Potvin C method.
Regards,
Mikalai
Complete thread:
- Appropriate wording for a protocol Elena777 2019-09-09 19:34
![[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 0.0294Mikalai 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 0.0294Mikalai 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-stage Astea 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-stage Astea 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