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Is there a method for replicated bioequivalence design with accordance to FDA guideline? #8

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chzhcpu opened this issue Jul 12, 2023 · 1 comment
Open

Is there a method for replicated bioequivalence design with accordance to FDA guideline? #8

chzhcpu opened this issue Jul 12, 2023 · 1 comment

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@chzhcpu
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chzhcpu commented Jul 12, 2023

Hi, Helmut01. It is a good work.
Is there a method for replicated bioequivalence data analysis with accordance to FDA guideline?
I do not find a packge doing that work.
@Helmut01
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THX!
There is no package. While it might be possible to code the RSABE-part (if swR ≥0.294), it is impossible to setup the mixed-effects model for ABE (if swR<0.294) exactly like in the FDA’s guidance.

Sorry for no better news.
Helmut

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@chzhcpu @Helmut01