Bioequivalence and Bioavailability Forum • AUC∞ = lousy metric

AUC∞ = lousy metric [NCA / SHAM]

posted by jag009 – NJ, 2013-06-19 23:20 (4383 d 19:31 ago) – Posting: # 10831
Views: 8,346

Hi Helmut,

❝ Duno. Maybe you can start an argument that AUC_∞ is not a reliable PK metric. According to the paper AUC_∞ is not only more variable, but may also be biased (depending on the PK model and the LLOQ). On the other hand both AUCs are required. Good luck.

Not trying to play genius but isn't that obvious since AUCinf is based on AUCt and a component which is based on extrapolation and in turn dependent on regression?

John

Complete thread:

Failing BE study due to AUCinf jag009 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 metricjag009 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