ICH M13A: Changes to Step 2 [BE/BA News]

posted by BEQool  – 2024-09-09 07:48 (28 d 04:57 ago) – Posting: # 24191
Views: 1,287

Hello all,

❝   – Final (page 12)

❝     Randomised, non-replicate, crossover design studies should be analysed using an appropriate parametric method, e.g., general linear model (GLM) or mixed model.

❝     […] The mixed model likely was a concession made to the FDA and Health Canada, the only agencies currently requiring it.


So we can either put subject as a fixed or random effect?

But then the following text comes up:
"The primary statistical analyses should include all data for all subjects who provide evaluable data for both the test and comparator products."

And also in Q&A document:
In a 2-way crossover design, if data from one period are excluded, the subject should not be included in the statistical analysis […]

I am confused, if I understand well, we should all treat subject as a fixed effect? :confused:

Regards
BEQool

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