‘alpha’ of scaled ABE? [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2013-03-15 16:27 (2981 d 02:22 ago) – Posting: # 10203
Views: 18,693

Dear Detlew!

» A rather natural choice IMHO would be to calculate the power at the border(s) of the widened BE acceptance limits.

Agree.

» GMR=1.25 if CV<=0.3 or GMR=exp(0.8925742*CV2se(CV)) if CV>0.3 for the FDA RSABE
» GMR=1.25 if CV<=0.3 or GMR=exp(0.7601283*CV2se(CV)) if CV>0.3 for the EMA scABEL and cap on if CV>0.5

<nitpicking>

I would prefer a GMR of 0.80 since PowerTOST employs simulations – remember the “rounding thread”? ;-)

</nitpicking>

Which designs / sample sizes have you used? I’m struggling reproducing your numbers.

» Interesting! At least for me :yes:.

For me as well. I will ask the two Lászlós and maybe Panos Macheras.

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
21,460 posts in 4,486 threads, 1,511 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Thursday 18:49 UTC (Europe/Vienna)

Nothing in the world is more dangerous
than sincere ignorance
and conscientious stupidity.    Martin Luther King, Jr.

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