In Phoenix templates any data mappings that are internal to the workflow are retained. For example, all expected output from the BQL objects, such as sub-ject, time, and concentration, are retained in the NCA objects’ Main Mappings panel. Mappings that are external to the template, such as the BQL rules and the data sets used with the BQL objects are not retained.
Create the template:
1. Select the Parallel BE workflow.
2. Click the Create Template button in the Object Browser toolbar to save the workflow as a template.
The Save Object dialog is displayed.
The default file type is Excel. Change this in the Save as type: menu to Phoenix Template (*.wnlt). The default file name is Parallel BE. Do not change this name.
3. Save the template in the Pharsight Projects Directory, which by default is located at C:\Documents and Settings\<user name>\My Doc-uments\Pharsight Projects or C:\Users\<user
name>\Documents\Pharsight Projects.
4. Ensure Save As type is Phoenix Template (*.wnlt) and click OK to save the Parallel BE workflow as a Phoenix Template (.wnlt) file.
The workflow is saved as a template file in the Pharsight Project directory and
Add the Parallel BE template to the project:
1. Select File > Import or click the Import button. The Open File(s) dialog is displayed.
2. Navigate to the Pharsight Projects Directory.
3. Select Parallel BE.wnlt and click Open.
The template is added to the project as a second workflow. The second workflow is nested below the first one. The new workflow is named Parallel BE 1.
4. Select Parallel BE 1 in the Object Browser.
5. Rename the workflow object Parallel BE 2.
Note: All references to workflows and operational objects in this section of the example refer to the Parallel BE 2 workflow and the operational objects it con-tains.
Map the BQL Rule Set to the BQL objects:
1. Select the Parallel BE 2 workflow object in the Object Browser.
The workflow object's Diagram tab is displayed in the right viewing panel.
2. Click the chevron buttons to expand BQL Brand and BQL Generic.
3. Click the (+) symbols to expand Rule Sets for both BQL objects.
4. Use the pointer to drag the Rule Set from the BQL Rules folder to the Rule Set input for both BQL Brand and BQL Generic.
5. Select BQL Brand in the Parallel BE 2 workflow. BQL Brand’s Setup tab is displayed in the right viewing panel.
6. Use the pointer to drag the Pococuranitol_data worksheet from the Data folder to BQL Brand’s Main Mappings panel.
7. Use the option buttons in the Main Mappings panel to map the data types to the following contexts:
• Map Subject to the Sort context.
• Map Time to the Time context.
• Map Concentration to the Concentration context.
• Leave all other data types mapped to None.
8. The template has retained the Output Column Name BrandConc_gt_0_01.
Do not change this name.
9. Click the Execute button. The results are displayed on the Results tab.
10.Select BQL Generic in the Parallel BE 2 workflow. BQL Generic’s Setup tab is displayed in the right viewing panel.
11.Use the pointer to drag the GenericForm2_data worksheet from the Data folder to the Main Mappings panel.
12.Use the option buttons in the Main Mappings panel to map the data types to the following contexts:
• Map Subject to the Sort context.
• Map Time to the Time context.
• Map Concentration to the Concentration context.
• Leave all other data types mapped to None.
13.The template has retained the Output Column Name GenericConc_gt_0_01.
Do not change this name.
14.Click the Execute button. The results are displayed on the Results tab.
Set up brand descriptive statistics:
1. Select Descriptive Stats Brand in the Object Browser to display its Setup tab in the right viewing panel.
• Descriptive Stats Brand was created using a template, so all mappings in the Main Mappings panel and all options selected in the Options tab are carried over from the original object.
• Because Descriptive Stats Brand used BQL Brand’s output as its input, and because BQL Brand has been executed in the second workflow, there is no need to make any changes to the Descriptive Stats object.
2. Click the Execute button. The results are displayed on the Results tab.
Set up generic descriptive statistics:
1. Select Descriptive Stats Generic in the Object Browser to display its Setup tab in the right viewing panel.
• Because Descriptive Stats Generic used BQL Generic’s output as its input, and because BQL Generic has been executed in the second workflow, there is no need to make any changes to the Descriptive Stats object.
2. Click the Execute button. The results are displayed on the Results tab.
Plot the concentration values over time:
1. Select XY Plot Brand vs Generic in the Object Browser to display its Setup tab in the right viewing panel.
• XY Plot Brand vs Generic was created using a template, so all mappings in the XY Data and XY 1 Data Mappings panels and all options selected in the Options tab are carried over from the original object.
• Because XY Plot Brand vs Generic used BQL Brand’s and BQL Generic’s output as its input, and because both BQL objects have been executed in the second workflow, there is no need to make any changes to the XY Plot object.
2. Click the Execute button. The results are displayed on the Results tab.
Examine the output. The plot shows that the concentration values peak at very different times in the two different study groups. The second generic formulation lasts longer and has much higher concentration values than the brand name for-mulation.
Plot the mean concentration values over time:
1. Select XY Plot Mean Brand vs Generic in the Object Browser to display its Setup tab in the right viewing panel.
• XY Plot Mean Brand vs Generic was created using a template, so all map-pings in the XY Data and XY 1 Data Mapmap-pings panels and all options selected in the Options tab are carried over from the original object.
• Because XY Plot Mean Brand vs Generic used Descriptive Stats Brand’s and Descriptive Stats Generic’s output as its input, and because both Descriptive Stats objects have been executed in the second workflow, there is no need to make any changes to the XY Plot object.
2. Click the Execute button. The results are displayed on the Results tab.
Examine the output. The plot shows that the mean concentration values peak at very different times in the two different study groups.
Set up brand noncompartmental analysis:
1. Select NCA Brand in the Object Browser to display its Setup tab in the right viewing panel.
• NCA Brand was created using a template, so all mappings in the Main Mappings panel and all options selected in the Options tab are carried over from the original object.
• Because NCA Brand used BQL Brand’s output as its input, and because BQL Brand has been executed in the second workflow, only a few changes need to be made to the NCA object.
• Because the dosing data came from a data source external to the template, the Dosing tab needs to be re-mapped.
Dosing regimen
In this example one dose of 50 mg was administered at time 0. The Pococurani-tol workbook contains a dosing data worksheet named PococuraniPococurani-tol_dose.
1. Select Dosing in the Setup list.
Map the Pococuranitol_dose worksheet as the input source for NCA Brand’s Dosing panel.
2. Use the pointer to drag the Pococuranitol_dose worksheet from the Data folder to NCA Brand’s Dosing Mappings panel.
The Pococuranitol_dose worksheet is mapped to NCA Brand’s Dosing Mappings panel.
3. Use the option buttons in the Dosing Mappings panel to map Subject to Sort, Dose to Dose, and Time_of_Dose to Time of Dose.
4. Click the Execute button. The results are displayed on the Results tab.
Set up generic noncompartmental analysis:
1. Select NCA Generic in the Object Browser to display its Setup tab in the right viewing panel.
• Because NCA Generic used BQL Generic’s output as its input, and because BQL Generic has been executed in the second workflow, only a few changes need to be made to the NCA object.
• Because the dosing data came from a data source external to the template, the Dosing tab needs to be re-mapped.
Dosing regimen
In this example one dose of 50 mg was administered at time 0. The GenericForm2 workbook contains a dosing data worksheet named GenericForm2_dose.
1. Select Dosing in the Setup list.
2. Use the pointer to drag the GenericForm2_dose worksheet from the Data folder to NCA Generic’s Dosing Mappings panel.
The GenericForm2_dose worksheet is mapped to NCA Generic’s Dosing Map-pings panel.
3. Use the option buttons in the Dosing Mappings panel to map Subject to Sort, Dose to Dose, and Time_of_Dose to Time of Dose.
4. Click the Execute button. The results are displayed on the Results tab.
Combine the NCA output:
Combine the Final Parameters Pivoted worksheets from both NCA objects and use the combined output in the bioequivalence model. The new column created by the Append Worksheets object will contain the formulation information for the bioequivalence model.
1. Select Append Worksheets in the Object Browser to display its Setup tab in the right viewing panel.
• Append Worksheets was created using a template, so all mappings in the Worksheet 1 and Worksheet 2 Mappings panel are carried over from the original object.
• Because Append Worksheets used NCA Brand’s and NCA Generic’s out-put as its inout-put, and because both NCA objects have been executed in the second workflow, no changes need to be made to the Append Worksheets object.
2. Click the Execute button. The results are displayed on the Results tab.
Edit the Append Worksheets output:
1. Right-click the Result worksheet in the Results tab and select Copy to Data Folder.
The worksheet is copied to the Data folder and renamed Result from Append Worksheets.
2. Select the Result from Append Worksheets worksheet in the Data folder.
3. Rename the worksheet Parallel BE Input 2.
The Columns tab is located underneath the right viewing panel. The Columns tab is used to edit columns in a worksheet.
4. Select the Source column header in the Columns box.
5. Click the column header once to make it editable.
6. Rename the column header to Formulation.
7. In the Formulation column rename NCA Brand to Brand.
8. Select the first cell in the Formulation column and type Brand.
9. Use the drag and fill feature to change all NCA Brand cells to Brand.
10.In the Formulation column rename NCA Generic to Generic 2.
11.Use the drag and fill feature to change all NCA Generic cells to Generic 2.
Set up the second bioequivalence model:
1. Select Bioequivalence in the Object Browser to display its Setup tab in the right viewing panel.
Map the Parallel BE Input 2 worksheet as the input source for the Bioequivalence object.
2. Use the pointer to drag the Parallel BE Input 2 worksheet from the Data folder to the Main Mappings panel.
The Parallel BE Input 2 worksheet is mapped to the Bioequivalence object.
• The Bioequivalence object was created using a template, so all mappings in the Main Mappings panel and all options selected in the Model tab are carried over from the original object.
• In the Model tab the Parallel/Other option button is selected, and the Ref-erence Formulation is set to Brand.
3. Click the Execute button. The results are displayed on the Results tab.
Examine the output.
Note: It is not necessary to keep a project open after completing each chapter. This project is not required when working in the next chapter. To close a project right-click the project and select Close Project.