Sereng
☆    

USA,
2022-05-12 17:14
(14 d 02:10 ago)

(edited by Sereng on 2022-05-12 17:53)
Posting: # 22974
Views: 212
 

 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

Biostatistically Challenged CEO
ElMaestro
★★★

Denmark,
2022-05-12 22:14
(13 d 21:10 ago)

@ Sereng
Posting: # 22979
Views: 168
 

 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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