Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

Handling large Extrapolated AUC Values [Regulatives / Guidelines]

posted by Sereng – USA, 2022-05-12 17:17 (15 d 01:10 ago) – Posting: # 22975
Views: 248

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:

Handling large Extrapolated AUC ValuesSereng 2022-05-12 17:17 [Regulatives / Guidelines]
- residual area < 20% for more than 80% subjects mittyri 2022-05-14 22:06
  - residual area < 20% for more than 80% subjects Sereng 2022-05-18 05:59
- Exclusion for the FDA? Helmut 2022-05-23 11:43

Admin contact
22,108 posts in 4,630 threads, 1,567 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time: Friday 18:27 CEST (Europe/Vienna)

We absolutely must leave room for doubt
or there is no progress and no learning.
There is no learning without having to pose a question.
And a question requires doubt.
People search for certainty.
But there is no certainty. Richard Feynman

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz