Achievwin
★    

US,
2022-05-20 04:44
(40 d 13:34 ago)

Posting: # 23005
Views: 341
 

 Switchability with replicate design studies [Design Issues]

Question for study design experts.

If we want to introduce assessment or claim using BE study which design is more appropriate? 3-way cross over partial study or 4-way cross full replicate design. Please share your experience.

Sincerely,

Achiewin


Edit: Category changed; see also this post #1[Helmut]
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2022-05-20 09:17
(40 d 09:01 ago)

@ Achievwin
Posting: # 23006
Views: 283
 

 Switchability = IBE

Hi Achievwin,

population BE (prescribability) and individual BE (switchability) are of historic interest only. Both are not assessed in any of the currently recommended approaches (average BE, reference-scaled BE, average BE with expanding limits).

» If we want to introduce assessment or claim using BE study which design is more appropriate?

Define ‘appropriate’. An appetizer.

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
Achievwin
★    

US,
2022-05-20 14:19
(40 d 03:59 ago)

@ Helmut
Posting: # 23007
Views: 262
 

 Switchability = IBE

» population BE (prescribability) and individual BE (switchability) are of historic interest only. Both are not assessed in any of the currently recommended approaches (average BE, reference-scaled BE, average BE with expanding limits).

Thanks for the clarification

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)

My question is can we assess this subject by formulation interaction in a 3-period partial replicate design?) what additional statistical test one needs for documenting this?
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2022-05-20 15:33
(40 d 02:45 ago)

@ Achievwin
Posting: # 23008
Views: 266
 

 S × F interaction

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
Achievwin
★    

US,
2022-05-20 23:32
(39 d 18:46 ago)

@ Helmut
Posting: # 23010
Views: 255
 

 S × F interaction

Thanks Helmut
UA Flag
Activity
 Admin contact
22,181 posts in 4,647 threads, 1,572 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Wednesday 18:18 CEST (Europe/Vienna)

Nerds don’t just happen to dress informally.
They do it too consistently.
Consciously or not, they dress informally
as a prophylactic measure against stupidity.    Paul Graham

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