statistical significance ≠ clinical relevance [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2025-12-23 14:52 (162 d 14:48 ago) – Posting: # 24538
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Hi Darborn,

❝ Has anyone ever encountered a BE study result where the CI did not include "1"?

Very rarely and only for drugs with low variability combined with unreasonably large sample sizes. For details see this article.

❝ If the regulatory agency asks for an assessment of whether bioequivalence can still be demonstrated, …

It demonstrates their lack of understanding the underlying concept of BE (statistical significance ≠ clinical relevance).

❝ … how should I reply?

See the last two sentences of the Summary of the linked article.
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