Bioequivalence and Bioavailability Forum • Failing BE study due to AUCinf

Failing BE study due to AUCinf [NCA / SHAM]

posted by jag009 – NJ, 2013-06-19 19:44 (4382 d 17:10 ago) – Posting: # 10822
Views: 9,625

Hi everyone,

Just out of curiosity. Has anyone seen a BE study failing due to AUCinf falling outside 80-125% and the variability in the results seem to be attributed to the determination of Kel (jumpy concentrations)? Sampling timepoint setup was adequate in terms of capturing the terminal eleminaition phase of the PK profile. I wonder if there is any way to save this study.

Thanks
John

Complete thread:

Failing BE study due to AUCinfjag009 2013-06-19 17:44
- AUC∞ = lousy metric Helmut 2013-06-19 18:15
  - AUC∞ = lousy metric jag009 2013-06-19 19:35
  - AUC∞ = lousy metric jag009 2013-06-19 21:20
    - AUC∞ = lousy metric Helmut 2013-06-20 17:29
      - AUC∞ = lousy metric jag009 2013-06-20 20:32
- Failing BE study due to AUCinf ElMaestro 2013-06-19 18:48
  - Failing BE study due to AUCinf jag009 2013-06-19 19:41
    - BS Helmut 2013-06-20 17:59
      - BS jag009 2013-06-20 20:35