Bioequivalence and Bioavailability Forum

Hi Anu,

❝ After running the WinNonlin software…

Which version?

❝ … for the Partially Replicate study I couldn't get Intrasubject variability directly (Unlike Fully Replicate and Cross over studies) …

Was the setup for conventional ABE (= unscaled) or RSABE (= my implementation of FDA’s code)? In the latter case only CV_WR is meaningful and part of the output.

I’m surprised that you got some output for a fully replicated design (I don’t). AFAIK Intrasubject CV is part of the standard output only for 2×2 cross-overs.

❝ … had done manual calculations on the available Var(Residual) by using the formula:

❝ Intrasubject CV = sqrt(exp(Residual_Variance) - 1).

Correct.

❝ The same problem had cropped up for Three way crossover study as well.

Also correct (see above).

❝ Kindly guide me how can I get the Intrasubject CV value directly from the software itself or can I put whole formula somewhere to get the CV.

All examples for ABE:

• Phoenix/WinNonlin 6.3
  • Run the Bioequivalence object
    
  • Output Data > Final Variance Parameters > Send to > Data > Data Wizard
    
  • Options > Filter > Add > ● Built In > Add… > Action [Include] > Find [Var(Residual)] > Column [Parameter] > Exclude ● Units, Parameter > OK
    
  • Options > Transformation > Add > Transformation Type [Custom] > New Column Name [CVintra] > Formula [100*sqrt(exp(Estimate)-1)]
• classical WinNonlin (≤5.3)
  • Run the Bioequivalence Wizard
    
  • Detach the result worksheet
    
  • Enter the formula in an empty cell, referring to the cell containing Var(Residual)
    
  • Refresh