Gender in crossover [R for BE/BA]

posted by nobody – 2018-02-28 10:14  – Posting: # 18480
Views: 4,817

» 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.

But if in, let's say, males Cmax is always 50% higher or AUC 40% lower you should see something in your data (plots)...

Totally out of discussion that it's not the purpose of BE-studies to investigate sex as a covariate in PK. But in the times of SJWs and alike you have to justify (!) if you don't want to have this aspect investigated in your BE-study.

Kindest regards, nobody

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