Bioequivalence and Bioavailability Forum • Playing around with α (not exactly brilliant)

Playing around with α (not exactly brilliant) [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2015-07-03 18:35 (4010 d 04:56 ago) – Posting: # 15037
Views: 9,946

Hi Helmut,

I see your points, however, but how did they relate to my point? I reckon we address two different aspects. It is likely a question of bad explanations on my part.
Consider this:

For any CV measured you can define a revised acceptance range while keeping the originally applied alpha (5%).
For any CV measured I can define a revised alpha that keeps the original acceptance range in place (80.00%-125.00%), and which achieves exactly the same (it rejects and accepts exactly the same products as your approach).

I can probably work out an example if you need one? Or someone well versed with stats can. Think of the principle, rather than how to exactly describe the relationship between scaled acceptance range and applied alpha while keeping the rejections/acceptances same.

My point was/is that changing the acceptance range for the CI in mathematical terms does exactly the same as keeping the acceptance range while changing the applied alpha.

—
Pass or fail!
ElMaestro

Complete thread:

HC Proposed Policy on Bioequivalence Standards for HVDS balakotu 2015-07-02 09:05
- HC Proposed Policy on Bioequivalence Standards for HVDS d_labes 2015-07-02 09:19
- Bloody partial replicate again Helmut 2015-07-02 13:20
  - Bloody partial replicate again Lucas 2015-07-02 13:35
    - Which model? Helmut 2015-07-02 16:41
      - Which model? Lucas 2015-07-02 18:06
- HC Proposed Policy on Bioequivalence Standards for HVDS drgunasakaran1 2015-07-02 17:08
  - AUC and Cmax Helmut 2015-07-02 17:37
- HC for HVDs d_labes 2015-07-03 08:21
  - HC for HVDs Helmut 2015-07-03 11:55
    - Rounding d_labes 2015-07-03 12:53
      - Acceptable difference (BE history) Helmut 2015-07-03 14:49
    - Off topic ElMaestro 2015-07-03 13:02
      - Playing around with α (not exactly brilliant) Helmut 2015-07-03 15:38
        
        Playing around with α (not exactly brilliant)ElMaestro 2015-07-03 16:35
        
        Playing around with α (not exactly brilliant) Helmut 2015-07-03 16:44
        
        OT – Philosophers on duty d_labes 2015-07-03 21:11