S × F interaction [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2022-05-20 17:33 (197 d 13:45 ago) – Posting: # 23008
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Hi Achievwin,

❝ 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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