Bioequivalence and Bioavailability Forum • Example w.o. intermediate power

Example w.o. intermediate power [Two-Stage / GS Designs]

posted by d_labes – Berlin, Germany, 2012-07-06 10:13 (4733 d 09:29 ago) – Posting: # 8898
Views: 21,278

Dear Helmut!

❝ ❝ I've heard some rumour from regulators that you should not stop but recruit 2 more subjects for stage 2 in that case. But this lacks any scientific justification IMHO.

❝ Yeah, but why not 2.718282 or 3.141593?

—
Regards,

Detlew

Complete thread:

Sequential designs, draft FDA guidance Loteprednol ElMaestro 2012-07-03 18:33 [Two-Stage / GS Designs]
- What the heck? Helmut 2012-07-03 19:25
  - some unofficial opinion with this regard in Europe Shuanghe 2012-07-04 09:07
    - Great! Helmut 2012-07-04 15:43
      - Great! Shuanghe 2012-07-05 13:48
        
        Potvin & Montague not acceptable at all?! Helmut 2012-07-05 14:57
        
        Powerless Potvin & Montague? d_labes 2012-07-05 16:11
        
        Example w.o. intermediate power Helmut 2012-07-06 02:06
        
        Example w.o. intermediate powerd_labes 2012-07-06 08:13
        
        Sims w.o. intermediate power Helmut 2012-07-26 16:20
        
        Potvin & Montague not acceptable at all?! ElMaestro 2012-07-05 16:20
        
        Sims? Helmut 2012-07-05 16:36