yogeshla
☆    

India,
2021-01-05 08:01
(1204 d 12:47 ago)

Posting: # 22173
Views: 2,480
 

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

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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 09:06
(1204 d 11:43 ago)

@ yogeshla
Posting: # 22174
Views: 2,084
 

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

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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 12:01
(1204 d 08:47 ago)

@ dshah
Posting: # 22177
Views: 1,968
 

 0.001 > 0

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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 13:33
(1204 d 07:15 ago)

@ Helmut
Posting: # 22178
Views: 1,921
 

 0.001 > 0

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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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