Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

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

posted by yogeshla – India, 2021-01-05 08:01 (765 d 01:33 ago) – Posting: # 22173
Views: 1,677

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

Admin contact
22,488 posts in 4,711 threads, 1,605 registered users;
23 visitors (0 registered, 23 guests [including 7 identified bots]).
Forum time: 09:34 CET (Europe/Vienna)

Many people tend to look at programming styles and languages like religions:
if you belong to one, you cannot belong to others.
But this analogy is another fallacy. Niklaus Wirth

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz