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RegisterUse data of all dosed subjects [Two-Stage / GS Designs]
posted by Helmut 
– Vienna, Austria, 2019-09-19 17:16 (2468 d 07:58 ago) – Posting: # 20617
Views: 18,406
Hi Elena,
Whatever drives the second stage, you have to use all data (Cmax and AUC). Whilst from a statistical perspective there would be no need to assess AUC (already BE in the first stage) no regulator would accept that. Once you dosed subjects, you have to use the data. No way out.
❝ […] What combined data should be evaluated after stage 2 completion: ONLY for Cmax or for Cmax and AUCt?
Whatever drives the second stage, you have to use all data (Cmax and AUC). Whilst from a statistical perspective there would be no need to assess AUC (already BE in the first stage) no regulator would accept that. Once you dosed subjects, you have to use the data. No way out.
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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 subjectsHelmut 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 subjectsHelmut 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-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