Bioequivalence and Bioavailability Forum • Handling large Extrapolated AUC Values

Handling large Extrapolated AUC Values [Regulatives / Guidelines]

posted by Sereng – USA, 2022-05-12 19:17 (1039 d 21:03 ago) – Posting: # 22975
Views: 2,948

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