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

posted by dshah  – India/United Kingdom, 2021-01-05 09:06 (1294 d 18:33 ago) – Posting: # 22174
Views: 2,383

Hi Yogeshla!

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


The 95% UB would not be acceptable for 0.001.

Regards,
dshah

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