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RegisterRobustness of bioequivalence when 90%CI doesn’t include 1 [Study Assessment]
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]
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]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- statistical significance ≠ clinical relevance Darborn 2025-12-24 01:07
- statistical significance ≠ clinical relevance Helmut 2025-12-23 13:52
Ing. Helmut Schütz