Bioequivalence and Bioavailability Forum

AUCextrap more than 20% [Study Assessment]

posted by Helmut – Vienna, Austria, 2013-08-01 14:52 (4714 d 05:37 ago) – Posting: # 11145
Views: 31,439

Hi Sam,

❝ I am also sure that if I repeat the study the study will qualify the BE criteria.

I am not sure about that (considering your bad PE, the low CVs, and the high sample size).

❝ But I have seen few cases in which if the %AUCextrap is more than 20% then the AUCt, AUCinf and all other secondary parameters were not calculated.

❝ Following cases Kel, T1/2, AUC0-inf, AUCt, Kel start and Kel stop will not be reported

❝ • Those subject exhibiting regression (Rsq) less than 0.8…

That’s a stupid criterion. Any cut-off based on the R²_adj doesn’t make sense.

❝ …i.e. non terminal log linear phase Kel, T1/2 and AUC0-inf will not be reported for that subject./period.

Make sense if λ_z cannot be reliably estimated (e.g., less than three data points).

❝ • For subjects /period exhibiting AUC_%Extrap_obs is greater than 20% .ie. AUC0-t/AUC0-inf ratios below 80%, Kel, T1/2 and AUC0-inf will not be reported.

Doubful for the FDA and definitely not acceptable for EMA (see my previous post).

❝ Kindly let me know if any of the cases applies here.

IMHO, no.

—
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Helmut Schütz

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Complete thread:

AUCextrap more than 20% sam 2013-08-01 06:15 [Study Assessment]
- AUCextrap more than 20% ElMaestro 2013-08-01 10:29
  - AUCextrap more than 20% sam 2013-08-01 11:21
    - AUCextrap more than 20% ElMaestro 2013-08-01 11:39
      - AUCextrap more than 20% sam 2013-08-01 12:01
        
        AUCextrap more than 20%Helmut 2013-08-01 12:52
    - forced BE d_labes 2013-08-01 11:59
      - Gambling ♠ ♣ ♥ ♦ Helmut 2013-08-01 13:31
- AUCextrap more than 20% Helmut 2013-08-01 12:32
  - AUCextrap more than 20% sam 2013-08-01 12:55
    - 46% power in study planning? Helmut 2013-08-01 13:18
      - 46% power in study planning? sam 2013-08-01 13:40
        
        46% power in study planning? jag009 2013-08-01 20:04
        
        Re-dosing Helmut 2013-08-02 03:32
        
        Re-dosing jag009 2013-08-02 05:10
        
        Re-dosing Helmut 2013-08-02 14:44
        
        46% power in study planning? sam 2013-08-02 07:00
        
        Carved in stone? Helmut 2013-08-02 03:22
        
        Carved in stone? sam 2013-08-02 07:02
        
        Carved in stone? luvblooms 2013-08-02 08:37
        
        Carved in stone? sam 2013-08-02 09:01
        
        Ethics (again) Helmut 2013-08-02 14:53
        
        Update jag009 2013-08-02 17:25
        
        Update Helmut 2013-08-02 18:11
        
        Update jag009 2013-08-02 20:11
        
        Outliers (CAN) Helmut 2013-08-02 20:56
        
        Outliers (CAN) jag009 2013-08-02 22:23
        
        OT: Expert Helmut 2013-08-03 10:11
        
        Update jag009 2013-08-02 22:29
        
        Update ElMaestro 2013-08-02 23:08
        
        Update jag009 2013-08-03 23:00
        
        Update luvblooms 2013-08-05 06:02
        
        Update jag009 2013-08-05 20:14

AUCextrap more than 20% [Study As­sess­ment]

Complete thread:

AUCextrap more than 20% [Study Assessment]