S × F interaction [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2022-05-20 17:33 (316 d 14:47 ago) – Posting: # 23008
Views: 794

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 🖖🏼 Довге життя Україна! [image]
Helmut Schütz

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

Complete thread:

UA Flag
 Admin contact
22,560 posts in 4,725 threads, 1,607 registered users;
18 visitors (0 registered, 18 guests [including 8 identified bots]).
Forum time: 08:20 CEST (Europe/Vienna)

No written law has ever been more binding than
unwritten custom supported by popular opinion.    Carrie Chapman Catt

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