AutoPilot Toolkit business rules

The following table summarizes the business rules that set formats and options for calculations and output in AutoPilot Toolkit. For each rule the table indicates whether the rule is approved for worksheet and graph output and whether the rule can be activated/deactivated or modified on a run-by-run basis. For details see the descriptions for each rule listed after the AutoPilot Toolkit Business Rules table.

Table 5: Business rules

Rule and page number for details

Tables

Graphs

Run-specific

Enable/Disable; default selection

General 

Context-sensitive footnotes

Y

Y

N

Y; disabled

Managing footnotes

Y

Y

N

 

PK parameter percent-extrapolated threshold

Y; enabled

– Calculation of summary values

Y

Y

N

– Footnote

Y

N

N

PK parameter Rsq adjusted threshold

 

 

 

Yes; enabled

– Calculation of summary values

Y

Y

N

– Footnote

Y

N

N

LOQ replacement

 

 

 

Y; some enabled

– Calculation of summary values

Y

Y

N

– Footnote

Y

N

N

Matrix mapping

Y

Y

N

Y; enabled

Summary statistics display for small sample sizes (Summary stat calculation criteria)

Y

Y

N

N; admin can set defaults

Summary statistics based on % threshold (Summary stat calculation criteria)

Y

Y

N

N; admin can set defaults

Individual values of zero treated as missing (Summary stat calculation criteria)

Y

Y

N

N; admin can set defaults

Exclusions

Y

Y

Y

Y; enabled

Tables 

General business rules

Y

N

Y; tables only; all footnotes on each split

N

Missing references in WinNonlin

Y

N

N

Y; enabled

Intext Table Template tab

Y

N

N

N

Display of different sample sizes in intext tables 

Y

N

N

Y; enabled

Significance level display in statistical tables 

Y

N

N

Y; enabled

Footnote about model time

Y

N

N

Y; enabled

RNT predose replacement

Y

Y

Y; set LOQ value only

Y; disabled

Display analyte and matrix information

Y

Y

Y

 

Time deviations

Y

N

N

N

Multiple analyte handling

Y

Y

 

 

Graphs 

Time scale algorithm

N

Y

N

Y; enabled

Categorical PK parameter graph X-axis split/offset

N

Y

Y

N

Display analyte and matrix information

Y

Y

Y

N; admin can set defaults

Axis starting points

 

 

 

N

– Display negative scale for X-axis/Y-axis

N

Y

N

– Force X-axis/Y-axis to start at zero

N

Y

N

Multiple analyte handling

Y

Y

 

 

Suppression of summary values below LOQ

N

Y

Y

 


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