Handling large Extrapolated AUC Values [Regulatives / Guidelines]

posted by Sereng  – USA, 2022-05-12 19:17 (654 d 23:37 ago) – Posting: # 22975
Views: 1,398

Dear Colleagues, despite best efforts (adequate sampling duration), if you should determine that one or more subjects contributes a large extrapolated AUC (>20%) in a BE study, how should we deal with it? Regards,

Biostatistically Challenged CEO

Complete thread:

UA Flag
 Admin contact
22,912 posts in 4,806 threads, 1,635 registered users;
29 visitors (0 registered, 29 guests [including 8 identified bots]).
Forum time: 17:54 CET (Europe/Vienna)

[…] an inappropriate study design is incapable of answering
a research question, no matter how careful the subsequent
methodology, conduct, analysis, and interpretation:
Flawless execution of a flawed design achieves nothing worthwhile.    J. Rick Turner

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