Sex in crossover [R for BE/BA]

posted by Helmut Homepage – Vienna, Austria, 2018-02-28 12:42  – Posting: # 18482
Views: 5,007

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.

Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes

Complete thread:

 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,514 posts in 4,141 threads, 1,336 registered users;
online 6 (0 registered, 6 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 22:47 CEST

We must be careful not to confuse data with the abstractions
we use to analyze them.    William James

BEBAC Ing. Helmut Schütz