Gender in crossover [🇷 for BE/BA]
❝ 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.
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Kindest regards, nobody
Kindest regards, nobody
Complete thread:
- randomization Ana Cristina 2018-02-23 21:33
- 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 crossover d_labes 2018-02-28 08:43
- Gender in crossovernobody 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 crossovernobody 2018-02-28 10:14
- Updated R-code Beholder 2020-04-08 12:31
- Gender in crossover d_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