Inclusion criteria in BE studies [Design Issues]

posted by BEQool  – 2023-05-05 12:42 (721 d 17:54 ago) – Posting: # 23543
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(edited on 2023-05-05 12:52)

❝ Just wish to mention that Gender is a between-subject factor (at least for most practical purposes ex-Thailand), so there is no particular gain in including Gender as a factor when you have Subject in the model unless there is a specific regulatory requirement.


Hello,
maybe a stupid question but is Gender*Treatment also a between-subject factor (like Sequence and Gender here)?
In the article Evaluation of sex-by-formulation interaction in bioequivalence studies of efavirenz tablets by González-Rojano et al. it doesnt say anything about which factor they used (within- or between-subject) to test Gender*Treatment interaction.

Additionally, how do you know which factor is a within-subject and which is a between-subject? If anyone has an explanation in simple words :-)

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