Bioequivalence and Bioavailability Forum • AUC∞ = lousy metric

AUC∞ = lousy metric [NCA / SHAM]

posted by Helmut – Vienna, Austria, 2013-06-20 19:29 (4381 d 15:55 ago) – Posting: # 10841
Views: 8,287

Hi John,

❝ 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?

Yes & no. The variability is higher because it depends on C_last which is expected to be the most variable data point of the profile. That’s trivial. More interesting is that AUC_∞ might also be biased – especially for two-compartment PK and caused by not always ‘catching’ the true λ_z in the area of LLOQ.

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Helmut Schütz

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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 metric jag009 2013-06-19 21:20
    - AUC∞ = lousy metricHelmut 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