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

posted by Sereng  – USA, 2022-05-12 19:14 (711 d 22:53 ago) – Posting: # 22974
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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

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