95% upper bound limit as per FDA for fully replicate crossover BE study [RSABE / ABEL]

posted by yogeshla – India, 2021-01-05 08:01 (765 d 01:33 ago) – Posting: # 22173
Views: 1,677

Hi All,

Can anyone confirm, till what decimal is acceptable for 95% upper bound limit as per FDA criteria?
Suppose 95% UB result is 0.001, is it acceptable to FDA?

Criteria is less than or equal to zero.

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

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