period within group and formulation [BE/BA News]

posted by mittyri – Russia, 2024-08-05 22:42 (128 d 08:48 ago) – Posting: # 24135
Views: 4,181

Dear Helmut,

❝ BE should be determined based on the overall treatment effect in the whole study population. The statistical model should take into account the multi-group nature of the BE study, e.g., by using a model including terms for group, sequence, sequence × group, subject within sequence × group, period within group and formulation. The group × treatment interaction term should not be included in the model. However, applicants should evaluate potential for heterogeneity of treatment effect across groups and discuss its potential impact on the study data, e.g., by investigation of group × treatment interaction in a supportive analysis and calculation of descriptive statistics by group.


"France lost the battle but she has not lost the war!"
I hope that we can see other improvements in the future.

By the way

Kind regards,
Mittyri

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