adjusted alpha by sims? [Two-Stage / GS Designs]

posted by d_labes  – Berlin, Germany, 2012-08-03 17:48 (4661 d 23:25 ago) – Posting: # 9034
Views: 14,512

Dear Helmut!

❝ 106 sims of Method B with αadj. 0.0380 (= quick-shot obtained from 104 sims) are running…


Don't overheat your machines :-D.

❝ BTW, where do you think Method B’s 0.0280 came from? :ponder:


If you mean Method D I guess: also from some trial and error.

Do you think doing some simulations in the planning phase and deciding the alpha's based on them will be acceptable to the mighty oracles in Europe?
What if the CV comes out other than supposed in the planning?

BTW: It's a similar question a good friend of our ol' pirate EM was once asked in respect to his method (see paper 6 of your post above):
"Do you think that it is acceptable to any regulator in Europe that the alpha of stage 2 isn't chosen a priori but depending on the results of stage 1, again via some simulation studies?"

Regards,

Detlew

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,668 registered users;
108 visitors (0 registered, 108 guests [including 5 identified bots]).
Forum time: 17:14 CEST (Europe/Vienna)

Freedom is always and exclusively
freedom for the one
who thinks differently.    Rosa Luxemburg

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