To pool or not to pool [Software]

posted by Helmut Homepage – Vienna, Austria, 2014-07-01 00:22 (3964 d 20:51 ago) – Posting: # 13182
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Hi Zan,

❝ Was it due to significant effect observed for Group x Treatment that resulted in the reviewer's decision to run final analysis by separate groups (on Page 5)?


Sure. The text contains a reference:

In control #98-392 (see attachment), it is stated that “if the Group-by-Treat­ment interaction is statistically significant (p<0.1), DBE requested that equi­va­lence be demonstrated in one of the groups, provided that the group meets mini­mum requirements for a complete bioequivalence study”.

However, #98-392 is not attached. I failed to dig it out at the FDA (controlled corres­pon­dence not covered by FOI?). Note the wording almost identical to my post above.

Please no more TOFU in future posts. THX.

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