S × F interaction [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2022-05-20 15:33 (48 d 03:18 ago) – Posting: # 23008
Views: 286

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.

Dif-tor heh smusma 🖖 [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,192 posts in 4,651 threads, 1,574 registered users;
online 10 (1 registered, 9 guests [including 1 identified bots]).
Forum time: Thursday 18:51 CEST (Europe/Vienna)

Any sufficiently advanced technology
is indistinguishable from magic.    Arthur C. Clarke

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5