Sex in crossover [R for BE/BA]

posted by Helmut Homepage – Vienna, Austria, 2018-02-28 12:42 (1333 d 16:18 ago) – Posting: # 18482
Views: 11,406

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.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
21,753 posts in 4,548 threads, 1,544 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Sunday 06:01 CEST (Europe/Vienna)

They were “so intent of making everything numerical”
that they frequently missed seeing
what was there to be seen.    Barbara McClintock

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5