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Achievwin ★ US, 2022-05-20 06:44 (257 d 13:33 ago) Posting: # 23005 Views: 715 |
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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] |
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Helmut ★★★   Vienna, Austria, 2022-05-20 11:17 (257 d 09:00 ago) @ Achievwin Posting: # 23006 Views: 633 |
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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 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Achievwin ★ US, 2022-05-20 16:19 (257 d 03:58 ago) @ Helmut Posting: # 23007 Views: 558 |
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❝ 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? |
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Helmut ★★★ Vienna, Austria, 2022-05-20 17:33 (257 d 02:44 ago) @ Achievwin Posting: # 23008 Views: 691 |
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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. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Achievwin ★ US, 2022-05-21 01:32 (256 d 18:45 ago) @ Helmut Posting: # 23010 Views: 596 |
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Thanks Helmut |
Ing. Helmut Schütz