I love your subject line! [General Sta­tis­tics]

posted by Helmut Homepage – Vienna, Austria, 2019-08-08 10:31  – Posting: # 20487
Views: 2,981

Ahoy, my Capt’n,

» » The precise model [:blahblah:]
»
» But on the other hand: Why then then include e.g. period?

[image]Cause otherwise eventual period effects would not mean out. ;-)

Given, sometimes one has to assume lacking period effects and everybody is happy with that. If an originator explores whether the drug follows linear PK, we have a paired design (SD → saturation → steady state) and compare AUC0–τ with AUC0–∞. A crossover would be a logistic nightmare.

» Let us for a moment disregard the actual wording. [lengthy beautiful explanation]

Exactly.

» […] For a parallel trial I think I want group in the model. If regulators don't like this, they can ask me to take it away. I happily do so without protesting. I am a sheep at that point. But not until then. :-D

Agree again.

Cheers,
Helmut Schütz
[image]

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