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

posted by dshah  – India/United Kingdom, 2021-01-05 08:06 (585 d 18:20 ago) – Posting: # 22174
Views: 1,239

Hi Yogeshla!

» Suppose 95% UB result is 0.001, is it acceptable to FDA?

The 95% UB would not be acceptable for 0.001.


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