Bioequivalence and Bioavailability Forum

Sex in crossover [🇷 for BE/BA]

posted by Helmut  – Vienna, Austria, 2018-02-28 13:42 (3017 d 23:46 ago) – Posting: # 18482
Views: 19,964

Hi nobody,

❝ […] it's not the purpose of BE-studies to investigate sex as a covariate in PK.

Agree. For ages we routinely included ♀/♂ in our studies. Bioanalysts were in with females cause their concentrations were higher…

❝ 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.

BfArM = early SJW? In March 2005 we received a deficiency letter. Relevant section in all of its doubtful beauty:

Gemäß §7 Abs. 2; Ziffer 12 GCP-V fehlt im Prüfplan eine Begründung dafür, dass die ge­wählte Geschlechter­verteilung in der Gruppe der betroffenen Personen zur Feststellung möglicher geschlechts­spezifischer Unterschiede bei der Wirksamkeit oder Unbedenklichkeit des geprüften Arzneimittels angemessen ist.

Heck, it was a “sprinkle study” and the drug has no sex-related differences in PK. Since that time, ♂ only.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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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 crossover nobody 2018-02-28 10:14
                • Sex in crossoverHelmut 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