Bioequivalence and Bioavailability Forum • Not enough subjects to say

Not enough subjects to say [Regulatives / Guidelines]

posted by Ohlbe – France, 2020-03-15 19:28 (198 d 14:10 ago) – Posting: # 21278
Views: 2,979

Dear SKM,

» » This could be a case of BE being present in males and not in females....
»
» In fact that's the case in the pilot.

With only 4 females in your study you don't have enough statistical power to make such a conclusion. You may have a signal, but I would find it difficult to go any further based on the data you have at hand currently.

—
Regards
Ohlbe

Complete thread:

Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-11 14:35 [Regulatives / Guidelines]
- Underrepresentation of female subjects in BE study to register Generic Ohlbe 2020-03-11 15:07
  - Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-11 15:37
    - Study planning 101 Helmut 2020-03-11 16:31
- Underrepresentation of female subjects in BE study to register Generic ElMaestro 2020-03-11 15:24
  - Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-11 16:15
    - Underrepresentation of female subjects in BE study to register Generic ElMaestro 2020-03-15 09:27
      - Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-15 09:41
        
        Underrepresentation of female subjects in BE study to register Generic ElMaestro 2020-03-15 10:23
        
        Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-16 09:13
        
        Not enough subjects to sayOhlbe 2020-03-15 19:28
        
        Not enough subjects to say ping4santosh 2020-03-16 09:03
- Underrepresentation of female subjects in BE study to register Generic jag009 2020-03-15 07:30
  - Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-15 09:43