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Click the Data Wizard button at the bottom of the PC Mapping page.
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Enter the numeric value with which to replace the text in the Source Data column.
In the image above, a zero (“0”) will replace any instance of “<LLOQ” in the PCORRES source data column. PK Submit stores the numeric values in a PCCALCN column in the Master PC worksheet, which is then combined with PCORRES to form a PKConc analysis variable. -
Use the two pull-down menus to define the target concentration unit (e.g., ng/mL).
These units are stored in the PCCALCNU column. PK Submit compares the units with those in PCORRESU and multiplies the values in PCORRES by the necessary factor to obtain the target units. -
Click OK.
Any text value detected in the data mapped to PCORRES is listed in the Data Converter tool.
According to FDA recommendations, test results that fall below the LOQ need to have “BLQ” in PCSTRESC. Although PK Submit supports a number of different file type imports, the nomenclature used by scientists for reporting LLOQ values varies greatly. As a result, the process of identifying LLOQ values and inserting ‘BLQ’ into PCSTRESC cannot be automated. However, using the Data Wizard, it is possible for you to create expressions specific to your data that will generate the appropriate entries in the PCSTRESC.
For this example, a result that fell below the LOQ is indicated in PCORRES by “< 0.1” (where 0.1 is the LLOQ value). First, look for “<“ in PCORRES and then place “BLQ” in the corresponding cell of a new column. Next, use the contents of the new column to replace the values in PCSTRESC.
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Using the Data Wizard, click + and enter a name for the new column (e.g., PCSTRESCBQL).
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Enter the expression:
IIF(PCORRES LIKE '%<%','BLQ',PCORRES) -
Click + to add a second column and enter PCSTRESC as the name.
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For the expression, enter the name used for the first new column (e.g., PCSTRESCBQL).
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Click Execute.
For your data, replace the “<“ in step 2 with the value or part of the value used in PCSTRESC to indicate LLOQ.
