Bioequivalence and Bioavailability Forum

AUCextrap more than 20% [Study Assessment]

posted by sam – India, 2013-08-01 14:01 (4711 d 02:09 ago) – Posting: # 11143
Views: 30,952

Hi ElMaestro,

❝ It is slightly surprising, I thought the PEs would be closer to unity, but be that as it may. You might be able to demonstrate BE by increasing the number of subjects slightly, all other factors equal.

Thanks for your suggestion. I am also sure that if I repeat the study the study will qualify the BE criteria. 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.

Also I have few more things in some literatures.

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 i.e. non terminal log linear phase Kel, T1/2 and AUC0-inf will not be reported for that subject./period.
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.
When 3 to 4 plasma /serum / blood sample is missing from terminal elimination phase points in sample collection schedule.
If volunteer in particular period show series of concentration below the limit of quantification followed by valid concentration above the LOQ in that cases AUC calculation will be handled case to case basis.

Kindly let me know if any of the cases applies here. So that I can apply in my study and save the study without further repeating the same.

Edit: Please don’t copy/paste from somewhere else without checking the Preview. Your post contained non-printable characters. [Helmut]

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]