Group effect in 2x2 BE study [Software]

posted by zan – US, 2014-06-30 21:18 (3948 d 02:08 ago) – Posting: # 13175
Views: 27,229

Thanks very much for the useful reply, ElMaestro and Helmut! Yes I am using Phoenix Winnonlin to work on this analysis. If there is a significant treatment*Group effect, is the overall (all subject) ratio (CI90%) still valid, or we have to adopt the ratio (CI90%) from separate groups?

Regarding FDA's requirement below (equiva­lence be demonstrated in one of the groups), do we have a link to the source of the letter? I am hoping to keep it as a reference for study files.

❝ If the Treatment-by-Group term is not significant (p ≥0.1) this term can be dropped from the model, proceeding to Group Model II.

❝ If the Treatment-by-Group term is significant (p <0.1), FDA’s Division of Bioequivalence requests that equiva­lence be demonstrated in one of the groups, provided that the group meets minimum requirements for a com­plete BE study (i.e., 12).


Best regards
zan

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