Sex in crossover [R for BE/BA]

posted by Helmut Homepage – Vienna, Austria, 2018-02-28 12:42  – Posting: # 18482
Views: 5,247

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 :love: 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.

Cheers,
Helmut Schütz
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