Achievwin
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US,
2022-05-20 06:44
(257 d 13:33 ago)

Posting: # 23005
Views: 715
 

 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
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Vienna, Austria,
2022-05-20 11:17
(257 d 09:00 ago)

@ Achievwin
Posting: # 23006
Views: 633
 

 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.

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Achievwin
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US,
2022-05-20 16:19
(257 d 03:58 ago)

@ Helmut
Posting: # 23007
Views: 558
 

 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
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2022-05-20 17:33
(257 d 02:44 ago)

@ Achievwin
Posting: # 23008
Views: 691
 

 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.

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Achievwin
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US,
2022-05-21 01:32
(256 d 18:45 ago)

@ Helmut
Posting: # 23010
Views: 596
 

 S × F interaction

Thanks Helmut
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