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RegisterSex in crossover [🇷 for BE/BA]
posted by Helmut 
– Vienna, Austria, 2018-02-28 13:42 (2393 d 02:05 ago) – Posting: # 18482
Views: 14,366
Hi nobody,
Agree. For ages we routinely included ♀/♂ in our studies. Bioanalysts were in
with females cause their concentrations were higher…
BfArM = early SJW? In March 2005 we received a deficiency letter. Relevant section in all of its doubtful beauty:
❝ […] 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!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- randomization Ana Cristina 2018-02-23 21:33 [🇷 for BE/BA]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- OT: Sex / gender Helmut 2018-02-28 14:58
- OT: Sex / gender d_labes 2018-02-28 14:42
- Gender in crossover nobody 2018-02-28 10:14
- Updated R-code Beholder 2020-04-08 12:31
- Gender in crossover d_labes 2018-02-28 08:43
- Updated R-code Helmut 2018-02-27 17:06
- Simplified R-code Ana Cristina 2018-02-27 13:16
- Simplified R-code Helmut 2018-02-26 15:46
Ing. Helmut Schütz