Bioequivalence and Bioavailability Forum • Significance

Significance [Power / Sample Size]

posted by The Outlaw Torn – Europe, 2012-11-20 09:55 (4608 d 20:25 ago) – Posting: # 9559
Views: 16,213

Hi ElMaestro,

❝ a 90% CI that doesn't spanover 1.0 should generally be no problem. It means that Test and Ref differ but so be it; all products differ and sometimes we can even detect it as a significant treatment effect as in your case. The primary equivalence criterion is still just a 90% CI within the acceptance range. Statistically different isn't necessarily clinically relevant.

This is my take on it as well and how I plan on pushing it (gently). What do you mean by "quality-focused"?

Thank you for your feedback.

Complete thread:

Significance The Outlaw Torn 2012-11-20 07:56
- Significance ElMaestro 2012-11-20 08:17
  - SignificanceThe Outlaw Torn 2012-11-20 08:55
    - Quality vs. Clinical ElMaestro 2012-11-20 09:04
- Sample size? Helmut 2012-11-20 20:10
  - Sample size? The Outlaw Torn 2012-11-21 07:52
  - Sample size? The Outlaw Torn 2012-11-22 10:55
    - Sample size, ratio, CV ↔ power Helmut 2012-11-22 13:35
      - Sample size, ratio, CV ↔ power The Outlaw Torn 2012-11-23 14:47
      - Sample size, ratio, CV ↔ power BEQool 2025-01-31 13:12
        
        TOST != treatment effect mittyri 2025-02-20 13:13
        Sample size, ratio, CV ↔ power zizou 2025-02-21 13:40
        
        Not vice versa mittyri 2025-02-22 21:08
        
        Not vice versa? zizou 2025-02-24 11:02
        
        Not vice versa? mittyri 2025-02-25 06:12
- Sample size calculation using Marzo and Balant method kumarnaidu 2013-01-31 07:48
  - Marzo / Balant formula d_labes 2013-01-31 10:05
    - Marzo / Balant formula kumarnaidu 2013-01-31 10:54
      - Marzo / Balant formula kumarnaidu 2013-02-04 05:48
        
        Marzo / Balant formula for parallel groups d_labes 2013-02-04 08:44