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

posted by yogeshla – India, 2021-01-05 08:01 (1200 d 16:04 ago) – Posting: # 22173
Views: 2,472

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]

Complete thread:

95% upper bound limit as per FDA for fully replicate crossover BE studyyogeshla 2021-01-05 07:01
- 95% upper bound limit as per FDA for fully replicate crossover BE study dshah 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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