(Expanded) BE limits, EMA-style [RSABE / ABEL]

posted by libaiyi – China, 2018-06-11 07:21 (898 d 10:42 ago) – Posting: # 18881
Views: 4,244

Hi,

I want to know how to figure out that whether the results are bioequivalence?

According to CFDA (China Food and Drug Administration) guidelines, when CVwR of Cmax is larger than 0.3, BE limits are fixed at (69.83, 143.19). Can we use the results from Mixed Model by SAS directly to determine if it falls between the limits or not? :-D:-D:-D

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