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RegisterS × F interaction [Design Issues]
posted by Helmut 
– Vienna, Austria, 2022-05-20 17:33 (1491 d 14:10 ago) – Posting: # 23008
Views: 6,283
Hi Achievwin,
No idea (too lazy to search).
Not sure whether it will work. The partial replicate is a nasty beast (for potential problems see there).
IIRC, in the late 1990s concerns about the Subject-by-Formulation interaction emerged. Temporarily studies had to be performed in a replicated design. After assessing the results, the FDA concluded that the S × F interaction is practically not relevant and the temporary requirement was lifted.
Furthermore, none of the simulations performed by various authors or by the FDA which lead to RSABE contained an S × F-interaction term in the model.
❝ I vaguely recall when you don't have subject by formulation interaction in a replicate study design (4-period full replicate design???) you can request switchability (Metadate ANDA I guess)
No idea (too lazy to search).
❝ […] can we assess this subject by formulation interaction in a 3-period partial replicate design?) what additional statistical test one needs for documenting this?
Not sure whether it will work. The partial replicate is a nasty beast (for potential problems see there).
IIRC, in the late 1990s concerns about the Subject-by-Formulation interaction emerged. Temporarily studies had to be performed in a replicated design. After assessing the results, the FDA concluded that the S × F interaction is practically not relevant and the temporary requirement was lifted.
Furthermore, none of the simulations performed by various authors or by the FDA which lead to RSABE contained an S × F-interaction term in the model.
—
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Helmut Schütz
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Science Quotes
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:
- Switchability with replicate design studies Achievwin 2022-05-20 04:44
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Switchability = IBE Helmut 2022-05-20 09:17
- Switchability = IBE Achievwin 2022-05-20 14:19
- S × F interactionHelmut 2022-05-20 15:33
- S × F interaction Achievwin 2022-05-20 23:32
- S × F interaction Brus 2023-06-06 11:02
- S × F interaction Helmut 2023-06-07 10:34
- S × F interaction Achievwin 2023-06-08 10:21
- S × F interaction Helmut 2023-06-07 10:34
- S × F interactionHelmut 2022-05-20 15:33
- Switchability = IBE Achievwin 2022-05-20 14:19
- Switchability = IBE Helmut 2022-05-20 09:17
Ing. Helmut Schütz