I love your subject line! [General Sta­tis­tics]

posted by Helmut Homepage – Vienna, Austria, 2019-08-08 10:31  – Posting: # 20487
Views: 529

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]

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

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,983 posts in 4,228 threads, 1,373 registered users;
online 11 (0 registered, 11 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 15:04 CET

I believe that a scientist looking at nonscientific problems
is just as dumb as the next guy.    Richard Feynman

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5