No – futile! – test for G×T, pleeze… [Study Performance]
Hi ElMaestro & PVRC,
Hundreds of studies accepted in the past without one. Seems to become increasingly fashionable recently.
Xactly. See there.
Yep.
Not even the highest dose of Schützomycin would help.
BTW, last month I endured a ‘Type A Meeting’ for an IND with the FDA.
I proposed to use ‘Model II’ without the stupid pre-test for a G × T interaction in ‘Model I’ because it inflates the Type I Error. Since writing a paper is on my todo-list for more than five years (
Nastia; I’m still collecting data), I was referring to my presentation at BioBridges in Prague 2018 (see esp. the backup-slides). Was accepted. 
❝ If this is a dossier for EU:
❝ 1. If you don't add a group effect, the regulator is likely to ask for it after submission.
Hundreds of studies accepted in the past without one. Seems to become increasingly fashionable recently.
❝ 2. If you do add a group effect, regulators are likely to ask you to submit a secondary analysis without it.
❝
Xactly. See there.
❝ At the end of the day Group is a between-factor, like sequence. Thus, the discussion is quite academic if we look at the confidence interval.
Yep.
❝ Another matter of course is if we, for some reason or other, take an interest in the p-value of the group effect itself or group x treatment. The latter sends shivers down my spine.
Not even the highest dose of Schützomycin would help.
BTW, last month I endured a ‘Type A Meeting’ for an IND with the FDA.
I proposed to use ‘Model II’ without the stupid pre-test for a G × T interaction in ‘Model I’ because it inflates the Type I Error. Since writing a paper is on my todo-list for more than five years (


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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:
- Additional Group in Bioequivalence Study PVRC 2021-04-23 10:35 [Study Performance]
- Additional Group in Bioequivalence Study ElMaestro 2021-04-23 12:17
- No – futile! – test for G×T, pleeze…Helmut 2021-04-23 15:14
- Additional Group in Bioequivalence Study ElMaestro 2021-04-23 12:27
- Additional Group in Bioequivalence Study PVRC 2021-05-06 12:22
- Additional Group in Bioequivalence Study ElMaestro 2021-04-23 12:17