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Robustness of bioequivalence when 90%CI doesn’t include 1 [Study Assessment]

posted by Darborn – Taiwan, 2025-12-23 09:55 (162 d 18:01 ago) – Posting: # 24536
Views: 1,842

Hi everyone,

Has anyone ever encountered a BE study result where the CI did not include "1"? If the regulatory agency asks for an assessment of whether bioequivalence can still be demonstrated, how should I reply?

Thank you!

Edit: Category changed; see also this post #1. [Helmut]

Complete thread:

Robustness of bioequivalence when 90%CI doesn’t include 1Darborn 2025-12-23 08:55 [Study Assessment]
- statistical significance ≠ clinical relevance Helmut 2025-12-23 13:52
  - statistical significance ≠ clinical relevance Darborn 2025-12-24 01:07
    - Δ (20% in general) Helmut 2025-12-24 09:59

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Robustness of bioequivalence when 90%CI doesn’t include 1 [Study As­sess­ment]

Complete thread:

Robustness of bioequivalence when 90%CI doesn’t include 1 [Study Assessment]