libaiyi
★    

China,
2021-02-02 09:39
(479 d 10:07 ago)

Posting: # 22199
Views: 1,302
 

 If we have any methods to widen CI in parallel design with high variance drug? [RSABE / ABEL]

Dear all,

Recently I meet a problem about sample size of high variance drug, normally, we will design a repeated cross-over trial for this kind of drug. But this time it is designed as a parallel study due to some reasons. But the sample size is too much based on 80%-125% BE CI. So my quesion is if we have any method to widen the CI like RSABE in cross-over study? Thank you very mcuh.:-D

Sincerely,
libaiyi
ElMaestro
★★★

Denmark,
2021-02-02 11:12
(479 d 08:34 ago)

@ libaiyi
Posting: # 22200
Views: 1,003
 

 If we have any methods to widen CI in parallel design with high variance drug?

Hi libaiyi,

» (...) So my quesion is if we have any method to widen the CI like RSABE in cross-over study?

I don't think there is any authority generally willing to widen the acceptance range in parallel trials involving humans (they'd perhaps do it if you were studying pMDI's in vitro etc).

Pass or fail!
ElMaestro
libaiyi
★    

China,
2021-02-02 11:40
(479 d 08:07 ago)

@ ElMaestro
Posting: # 22201
Views: 1,002
 

 If we have any methods to widen CI in parallel design with high variance drug?

Get it! Thank you Sir! :ok:


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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