Bioequivalence and Bioavailability Forum • Gender in crossover

Gender in crossover [🇷 for BE/BA]

posted by nobody – 2018-02-28 11:14 (2242 d 19:04 ago) – Posting: # 18480
Views: 13,427

❝ 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

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
        
        Updated R-code Beholder 2020-04-08 12:31