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Dear Dave/Helmut,
I am regularly reading this forum but not a part.
I want some understanding about group effect,
As i know when we do any study (BE) in two or multiple groups,
requires group factor incorporation in the ANOVA analysis, kindly give
me the detail about the model (fixed and random).
If our study pass with good limits and group effects [group*treatment]
comes significant either one or both the groups then can we justify to
regulatory about the same.
Recently we have received query from regulatory for the same, we used
model wrong.
Best if u could reply to mail directly without linking with forum.
Regards,
Sweety Shah
Clinical Research
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