Bioequivalence and Bioavailability Forum

Hi Angus,

❝ […] But precisely what information is transformed and where is the location of the data columns for the transformations.

Oops, terribly sorry! I rarely calculate CV_inter from a cross-over – I have my validated templates ready, which I avoid to touch. Actually you need two DWs, each consisting of both a filter and the transformation. In the BE results, navigate to the Final Variance Parameters-tab.

Data Wizard 1
• Filter ⇒ Built In ⇒ Add ⇒ Include: Var(Residual) ⇒ Column Parameter
  Alternatively: ⇒ Custom (Include) ⇒ Add ⇒ Parameter='Var(Residual)'
  
• Transformation ⇒ Transformation Type: Custom ⇒ New Column Name: CVintra ⇒
  Formula: 100*sqrt(exp(Estimate) - 1)

Data Wizard 2
• Filter ⇒ Built In ⇒ Add ⇒ Include: Var(Sequence*Subject) ⇒ Column Parameter
  Alternatively: ⇒ Custom (Include) ⇒ Add ⇒ Parameter='Var(Sequence*Subject)'
  
• Transformation ⇒ Transformation Type: Custom ⇒ New Column Name: CVinter ⇒
  Formula: 100*sqrt(exp(Estimate) - 1)

Now Join both Results, Sort by Dependent, map as source only the respective CVs (getting rid of the variances):


Here you are:



If you want you can join it with the Average BE results (mapping only relevant variables) getting:



It’s easy now to come up with a nice table for the report (FDA’s rounding to two decimal places of the PE/CI, four significant digits of the CVs):



Hope that helps. This was a pilot study with similarly low CV_intra than yours. I greyed out the products.
Sorry for the confusion caused in my OP.

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BTW, concerning our last week’s conversation on Pharsight’s Extranet: Below an example of scheduled/actual times and concentrations. Generally six to eight subjects and up to three treatments fit on a single page in portrait orientation.



Happy coding!