Bioequivalence and Bioavailability Forum • Well done!

Well done! [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2012-10-09 21:43 (4600 d 08:07 ago) – Posting: # 9362
Views: 14,102

Dear Detlew,

good anwer!

❝ On the other hand the reliable estimation of the terminal rate constant which is needed for a reliable estimate of AUC(0-inf) has the one and only purpose to assure that the observation time is long enough for ensuring that AUC(0-tlast) covers at least 80% of the AUC(0-inf) (or the other way round that the residual area AUC(tlast-inf) is <=20% of AUC(0-inf)).

❝

❝ AUC(0-inf) in itself is not a primary endpoint on which the bioequivalence decision will be based (not according to the EMA guidance and also not according to the Study protocol). The bioequivalence decision taken in the Study Report is thus in no way affected by the way of calculation of the terminal rate constant.

Agree, but some hard-core assessor might tell you that if you cannot reliably estimate AUC_∞ you have not demonstrated that AUC_t is an acceptable metric for the BE assessment. That’s a vicious circle.

BTW, I didn’t want to go to much off-topic (as I did above) and started another thread about analytical variability.

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Helmut Schütz

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Complete thread:

SAS error in 3 way ref replicate study AB 2012-05-04 15:13
- SAS error in 3 way ref replicate study jag009 2012-05-04 15:36
  - SAS error in 3 way ref replicate study AB 2012-05-05 06:45
- FDA's ABE code and partial replicate design d_labes 2012-05-06 10:10
  - Arbitrary (and unjustified) cut-off of r² Helmut 2012-05-06 13:29
    - Anscombe quartet d_labes 2012-05-07 08:48
      - Anscombe quartet in R Helmut 2012-05-07 11:15
        
        Anscombe quartet in R AB 2012-05-07 12:07
    - Arbitrary (and unjustified) cut-off of r² FI 2012-10-08 10:39
      - Predominant half life; exclusions Helmut 2012-10-08 13:45
        
        Excluding time points for lambdaZ d_labes 2012-10-09 09:33
        
        Analytical variability Helmut 2012-10-09 14:09
        
        Answer machine d_labes 2012-10-09 15:15
        
        Well done!Helmut 2012-10-09 19:43