S × F interaction [Design Issues]
❝ 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.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
The quality of responses received is directly proportional to the quality of the question asked. 🚮
- Switchability with replicate design studies Achievwin 2022-05-20 04:44 [Design Issues]
- Switchability = IBE Helmut 2022-05-20 09:17