Sereng
☆    

USA,
2022-05-12 19:14
(686 d 05:08 ago)

Posting: # 22974
Views: 1,256
 

 BE Confidence Interval Criteria: AUC(t) or AUC(inf) or both? [Regulatives / Guidelines]

Dear colleagues, for BE determination, in addition to Cmax, do we need to meet the 90% CI for both AUCt and AUCinf? Regards, Sereng

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ElMaestro
★★★

Denmark,
2022-05-13 00:14
(686 d 00:09 ago)

@ Sereng
Posting: # 22979
Views: 970
 

 BE Confidence Interval Criteria: AUC(t) or AUC(inf) or both?

Hi Sereng,

❝ ....do we need to meet the 90% CI for both AUCt and AUCinf?


Yes.

Pass or fail!
ElMaestro
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