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

posted by libaiyi – China, 2018-06-11 07:21 (1065 d 01:04 ago) – Posting: # 18881
Views: 4,650

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

Complete thread:

Activity
 Admin contact
21,446 posts in 4,483 threads, 1,511 registered users;
online 21 (1 registered, 20 guests [including 7 identified bots]).
Forum time: Tuesday 08:26 CEST (Europe/Vienna)

The fact that some geniuses were laughed at
does not imply that all who are laughed at are geniuses.    Carl Sagan

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5