Bioequivalence and Bioavailability Forum • PBE and IBE in WinNonlin

PBE and IBE in WinNonlin [Software]

posted by Helmut – Vienna, Austria, 2008-12-30 17:04 (5741 d 18:45 ago) – Posting: # 2991
Views: 29,158

Dear MGR!

❝ In the previous reply, you have given the output of WinNonlin like […],

This was the evaluation for Average Bioequivalence (ABE). In WinNonlin’s BE Wizard entry window:

  Type of Bioequivalence                     

    ⦿ Average       ○ Population/Individual

❝ […] Can we find the Switchability, Prescribability and Global Variance from the above data in Winnonlin?

Prescribability is assessed by Population Bioequivalence (PBE); Switchability by Individual Bioequivalence (IBE). In WinNonlin's BE Wizard entry window:

  Type of Bioequivalence                     

    ○ Average       ⦿ Population/Individual

❝ If so can you please give me the formulas to calculate these parameters?

For a basic reference see

Hauck WW, Andersons. Measuring Switchability and Prescribability: When Is Average Bioequivalence Sufficient? J Pharmacokin Biopharm. 1994; 22(6), 551–64

Just run the BE Wizard. For lnC_max of the example data set we get:


Population Bioequivalence Statistics



    Difference (Delta) : -0.129898

           Ratio(%Ref) : 87.818513

                SigmaR : 0.999918

 Reference-scaling eta : -1.875611,    Upper limit : -1.149187

  Constant-scaling eta : -0.118141,    Upper limit : 0.294625

      sigmaR > sigmaP? : yes, mixed scaling uses reference-scaling eta



           Conclusions : BE shown for ratio test.

                         Population BE shown for refnc-scaling CI test.

                         Population BE not shown for const-scaling CI test.

                         Population BE shown for mixed-scaling CI test.



Individual Bioequivalence Statistics



    Difference (Delta) : -0.129898

           Ratio(%Ref) : 87.818513

               SigmaWR : 0.448099

 Reference-scaling eta : -0.516803,    Upper limit : -0.234932

  Constant-scaling eta : -0.115652,    Upper limit : 0.041727

     sigmaWR > sigmaI? : yes, mixed scaling uses reference-scaling eta



           Conclusions : BE shown for ratio test.

                         Individual BE shown for refnc-scaling CI test.

                         Individual BE not shown for const-scaling CI test.

                         Individual BE shown for mixed-scaling CI test.

❝ […] in the protocol they had mentioned these parameters.

Not knowing how to evaluate the study? :lol3:

IMHO both PBE and IBE are of historic interest only.

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Helmut Schütz

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Complete thread:

SAS code of partial replicate design pa1kumar.anna 2008-12-01 09:51 [Software]
- Etiquette Ohlbe 2008-12-01 10:45
- SAS code for what? d_labes 2008-12-02 09:17
  - partial replicate = 3-period replicate Helmut 2008-12-03 15:42
    - partial replicate = 3-period replicate MGR 2008-12-04 11:19
    - 3-period replicate designs and SAS d_labes 2008-12-04 14:17
      - Extra-reference or partial replicate design d_labes 2008-12-12 10:51
        
        Extra-reference or partial replicate design Helmut 2008-12-12 11:34
        
        Simple minded d_labes 2008-12-12 13:28
        
        Simple minded Helmut 2008-12-12 14:58
        
        SAS and WinNonlin d_labes 2008-12-12 15:44
        
        SAS and WinNonlin Helmut 2008-12-12 16:33
        
        SAS and WinNonlin BEQool 2024-07-29 09:38
        
        Phoenix RSABE-template Helmut 2024-07-29 13:29
        
        Phoenix RSABE-template BEQool 2024-07-29 19:47
        
        CVw in Phoenix RSABE-template Helmut 2024-07-30 09:15
        
        CVw in Phoenix RSABE-template BEQool 2024-07-30 10:56
        
        CVw in Phoenix RSABE-template and PowerTOST CI2CV() Helmut 2024-07-30 11:23
        
        CVw in Phoenix RSABE-template and PowerTOST CI2CV() BEQool 2024-07-31 05:49
        
        General ABE? mittyri 2024-07-31 18:25
        
        General ABE? BEQool 2024-08-01 05:45
        
        Switchability and Prescribability in WinNonlin MGR 2008-12-30 10:12
        
        PBE and IBE in WinNonlinHelmut 2008-12-30 16:04
        
        PBE and IBE in WinNonlin MGR 2008-12-31 07:52
        
        Switchability NPavan 2009-01-12 13:10