Bioequivalence and Bioavailability Forum • 95% upper bound limit as per FDA for fully replicate crossover BE study

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

posted by yogeshla – India, 2021-01-05 08:01 (1641 d 20:57 ago) – Posting: # 22173
Views: 4,470

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 [RSABE / ABEL]
- 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