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.


Edit: Category changed; see also this post #1[Helmut]
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
★★★
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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.

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yogeshla
☆    

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

@ Helmut
Posting: # 22178
Views: 1,149
 

 0.001 > 0

Thanx !!


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]
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