Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-10-17 00:02 CEST (UTC+2h)
 

Potvin C in the EU [Two-Stage / GS Designs]

posted by Helmut Homepage - Vienna, Austria, 2013-04-16 17:40  - Posting: # 10424
Views: 15,229

Dear all,

new experiences from an ongoing MRP. Two studies (first one in two groups due to logistic reasons), Method C (!), all metrics in both studies passed in stage 1 (>80% power in the interim, no α-adjustment = 90% CIs).

Studies’ models in stage 1:
  1. Fixed:  sequence, period, treatment, group, group × treatment
    Random: subject(sequence)

  2. Fixed:  sequence, period, treatment
    Random: subject(sequence)
Accepted by Germany (RMS); no comments from Austria, Denmark, Sweden, and The Netherlands. Spain:

“Statistical analysis should be GLM. Please justify. Please provide the NOL.”

OK, I will repeat the analyses with all fixed effects (sigh; identical CIs…). ;-)
BTW, does anybody know what “NOL” means?

P.S.: All metrics would have passed with αadj 0.0294 (Method B) as well. I did not report these results and interestingly surprisingly was not asked for them.

[image]All the best,
Helmut Schütz 
[image]

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

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
17,394 Posts in 3,725 Threads, 1,071 registered users;
26 users online (0 registered, 26 guests).

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed