Bioequivalence and Bioavailability Forum • Impact of minimum stage 2 sample size on the Type I Error

Impact of minimum stage 2 sample size on the Type I Error [Two-Stage / GS Designs]

posted by ElMaestro – Denmark, 2016-12-30 13:12 (3464 d 11:38 ago) – Posting: # 16910
Views: 8,790

Hi Helmut,

I am sure you are right but I can't follow you, I mean can't readily understand what question you tried to answer.
So let me ask the forbidden question: "Can you reformulate?"

❝ Higher sample size ⇒ more degrees of freedom ⇒ narrower CI ⇒ higher probability to pass BE.

❝ In other words, the TIE will also increase and one would have to use a lower adjusted α.

This is one thing I did not get. Does that logic also work when we simulate true GMR 0.8 or 1.25 for type I error? I find it hard to convince myself.

Somehow I guess regulators just wanted to say that inclusion of a single subject in stage 2 would not be ok. They are right and that is not rocket science.

—
Pass or fail!
ElMaestro

Complete thread:

Impact of minimum stage 2 sample size on the Type I Error Helmut 2016-12-30 01:22
- Impact of minimum stage 2 sample size on the Type I ErrorElMaestro 2016-12-30 12:12
  - Impact of minimum stage 2 sample size on the TIE: example Helmut 2016-12-30 14:01
    - Impact of minimum stage 2 sample size on the TIE: example ElMaestro 2016-12-30 17:19
      - Impact of minimum stage 2 sample size on the TIE: example Helmut 2016-12-30 18:00
        
        Impact of minimum stage 2 sample size on the TIE: example ElMaestro 2016-12-30 18:50
        
        Bingo! Helmut 2016-12-30 19:00