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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 (381 d 04:25 ago) – Posting: # 22174
Views: 1,020

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

Complete thread:

95% upper bound limit as per FDA for fully replicate crossover BE study yogeshla 2021-01-05 07:01 [RSABE / ABEL]
- 95% upper bound limit as per FDA for fully replicate crossover BE studydshah 2021-01-05 08:06
  - 0.001 > 0 Helmut 2021-01-05 11:01
    - 0.001 > 0 yogeshla 2021-01-05 12:33

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