Groups: (Hardly‽) overlapping CIs [Design Issues]

posted by BEQool  – 2024-11-22 13:32 (558 d 11:06 ago) – Posting: # 24291
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Hello Helmut,

thank you for the example provided. Unfortunately, these kind of deficiency questions will probably become inevitable when conducting a study in groups.

❝ […] a separate exploratory analysis of each group was performed and produced the following outcomes

Did you perform this exploratory analysis of each group or did the agency do it?

❝ Therefore, the applicant should provide a justification for this difference and discuss its potential impact on the conclusion of bioequivalence.

❝ A new term: Hardly overlapping CIs. Again: So what? Justification?

How do you plan to "justify" this difference?

Regards
BEQool

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