Gender in crossover [🇷 for BE/BA]

posted by d_labes  – Berlin, Germany, 2018-02-28 09:43 (2334 d 03:25 ago) – Posting: # 18478
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Dear Helmut, dear Ana,

again asked: Why do you want to randomize gender (sex)?

Usually we randomize factors we want control for.
But you can't control for gender (sex) in crossover experiments as long as you have subject in your evaluation model.
Try it. Make an ANOVA with factors subject, period, treatment and additional gender.
It bombs you out! Because subject and gender are confounded.

Moreover it is highly debatable that gender differences are observable in crossover designs where we deal with differences between Test and Reference, both with the same active API in it.
If there are gender differences in response to the API they are supposedly present in both formulations and cancel out.
If not you have a gender-by-treatment interaction, aka subject-by-treatment interaction. The times of such an term are gone long years before when the "individual bioequivalence" was disestablished.

Regards,

Detlew

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