Bioequivalence and Bioavailability Forum • AUC∞ = lousy metric

AUC∞ = lousy metric [NCA / SHAM]

posted by jag009 – NJ, 2013-06-20 22:32 (4335 d 08:21 ago) – Posting: # 10843
Views: 7,782

Hi Helmut,

❝ 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.

Agree especially when the value is low enough to approach LLoQ.

❝ 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.

Exactly but for BE purposes (I mean ANDA) which is limited to Non-compartmental analysis (correct me if I wrong), this alone will lead to biased estimation of Kel.

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 metric jag009 2013-06-19 21:20
    - AUC∞ = lousy metric Helmut 2013-06-20 17:29
      - AUC∞ = lousy metricjag009 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