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Hello, both,
» » At this situation, should this subject's data with one period be included in the BE assessment?
»
» No, you could not.
We do not need a T-R comparison in each subject to do an analysis. We are just stuck in that paradigm. We could in principle fit a model with missing period data. And all data could be used for the calculation of the CI.
I do not know why there is a regulatory tradition for only using completers - I would say there is even a potential scientific and ethical advantage of using all period data.
» » At this situation, should this subject's data with one period be included in the BE assessment?
»
» No, you could not.
We do not need a T-R comparison in each subject to do an analysis. We are just stuck in that paradigm. We could in principle fit a model with missing period data. And all data could be used for the calculation of the CI.
I do not know why there is a regulatory tradition for only using completers - I would say there is even a potential scientific and ethical advantage of using all period data.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Should those subjects have only one period data be included in BE analysis? ssussu 2019-12-06 10:58 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- No way! But... Beholder 2019-12-06 12:36
- No way! But...ElMaestro 2019-12-06 13:14
- No way! But... Helmut 2019-12-06 14:47
- No way! But... PharmCat 2019-12-06 23:46
- No way! But... wienui 2019-12-07 04:01
- EMA guideline: no way...: mittyri 2019-12-07 20:58
- EMA guideline: no way...: wienui 2019-12-09 05:25
- EMA guideline: no way...: mittyri 2019-12-07 20:58
- Slightly off topic, but related :-) ElMaestro 2019-12-08 01:31
- Slightly off topic, but related :-) Shuanghe 2019-12-09 12:00
- Slightly off topic, but related :-) PharmCat 2019-12-09 15:13
- Slightly off topic, but related :-) ElMaestro 2019-12-21 15:02
- Slightly off topic, but related :-) PharmCat 2019-12-22 01:12
- 2.220446e-16 ≈ 0 Helmut 2019-12-22 10:37
- The optional tolerance argument ElMaestro 2019-12-23 14:37
- 2.220446e-16 ≈ 0 PharmCat 2019-12-24 14:18
- Sum of residuals ~ ε Helmut 2019-12-24 14:54
- Sum of residuals ~ ε ElMaestro 2019-12-24 15:10
- Wrong terminology Helmut 2019-12-28 13:55
- Sum of residuals ~ ε PharmCat 2019-12-24 18:40
- Sum of residuals ~ ε ElMaestro 2019-12-24 15:10
- Sum of residuals ~ ε Helmut 2019-12-24 14:54
- Slightly off topic, but related :-) ElMaestro 2019-12-21 15:02
- No way! But... wienui 2019-12-07 04:01
- No way! But... PharmCat 2019-12-06 23:46
- No way! But... Helmut 2019-12-06 14:47
- No way! But...ElMaestro 2019-12-06 13:14
- No way! But... Beholder 2019-12-06 12:36
Ing. Helmut Schütz