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Register95% upper bound limit as per FDA for fully replicate crossover BE study [RSABE / ABEL]
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]
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 [RSABE / ABEL]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 95% upper bound limit as per FDA for fully replicate crossover BE study dshah 2021-01-05 08:06
Ing. Helmut Schütz