yogeshla
☆

India,
2021-01-05 07:01
(585 d 18:18 ago)

Posting: # 22173
Views: 1,454

95% 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.

dshah
★

India/United Kingdom,
2021-01-05 08:06
(585 d 17:13 ago)

@ yogeshla
Posting: # 22174
Views: 1,239

95% upper bound limit as per FDA for fully replicate crossover BE study

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
Helmut
★★★

Vienna, Austria,
2021-01-05 11:01
(585 d 14:17 ago)

@ dshah
Posting: # 22177
Views: 1,163

0.001 > 0

Hi dshah and Yogeshla,

» The 95% UB would not be acceptable for 0.001.

Correct.

@Yogeshla: For the background see this post.

Dif-tor heh smusma 🖖
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
yogeshla
☆

India,
2021-01-05 12:33
(585 d 12:46 ago)

@ Helmut
Posting: # 22178
Views: 1,149

Thanx !!