Gender in crossover [🇷 for BE/BA]
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.
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
Regards,
Detlew
Complete thread:
- randomization Ana Cristina 2018-02-23 21:33 [🇷 for BE/BA]
- randomization ElMaestro 2018-02-23 22:24
- randomization Ana Cristina 2018-02-24 16:47
- randomization ElMaestro 2018-02-24 17:32
- package randomizeBE for R on steroids Helmut 2018-02-24 17:52
- Randomization of gender d_labes 2018-02-26 11:56
- Simplified R-code Helmut 2018-02-26 15:46
- Simplified R-code Ana Cristina 2018-02-27 13:16
- Updated R-code Helmut 2018-02-27 17:06
- Gender in crossoverd_labes 2018-02-28 08:43
- Gender in crossover nobody 2018-02-28 10:14
- Sex in crossover Helmut 2018-02-28 12:42
- Sex in crossover Helmut 2018-02-28 12:27
- OT: Sex / gender d_labes 2018-02-28 14:42
- OT: Sex / gender Helmut 2018-02-28 14:58
- OT: Sex / gender Ana Cristina 2018-03-01 03:16
- OT: Sex / gender Helmut 2018-02-28 14:58
- OT: Sex / gender d_labes 2018-02-28 14:42
- Gender in crossover nobody 2018-02-28 10:14
- Updated R-code Beholder 2020-04-08 12:31
- Gender in crossoverd_labes 2018-02-28 08:43
- Updated R-code Helmut 2018-02-27 17:06
- Simplified R-code Ana Cristina 2018-02-27 13:16
- Simplified R-code Helmut 2018-02-26 15:46