Release Notes - Pharsight

WinNonlin ® 5.3 Release Notes Known issues in Version 5.3
IVIVC validation fails when there are a different number of subjects in different studies
and one study has only one subject (QC 2470): If a crossover study, for example, has multiple
formulations and studies, and one study has a different number of subjects and one study has one
subject, the validation process fails. The failure occurs when mean profiles are used for external
validation.
Entering reserved keywords into a custom model IVIVC causes errors in the IVIVC
Wizard (QC 2471): If a custom IVIVC model uses the terms Tcut and Xcut instead of Tcutt and
Xcutt, for example, the model fails, because Tcut and Xcut are reserved keywords.
IVIVC error occurs in the prediction step when eleven formulations are used in a data set
(QC 2489): An error is created in IVIVC when too many formulations are used in the prediction
step. This causes the validation results to not match the prediction results.
IVIVC does not work if the file DefaultNCAParameterNames.map is placed in the
WinNonlin installation directory (QC 2502): This defect occurs because if Cmax or any AUC
parameter is renamed, then the IVIVC Wizard cannot find the correct output columns in the
NCA output in the Validation and Prediction steps. The workaround is to remove
DefaultNCAParameterNames.map from the WinNonlin installation directory.
The Prediction Dissolution Model should default to In-Vitro selection (QC 2503): The
Dissolution Model selected in the In-Vitro tab of the IVIVC Wizard should be automatically
selected as the Dissolution Model in the Prediction tab, but it is not.
Known issues in Version 5.3
Saved .lml files do not work correctly when used with a different workbook (QC 505): If a
user creates a Bioequivalence project and saves it as an .lml file, and uses the .lml file with
another workbook with the same column headers as the original workbook but in a different
order, the Bioequivalence Model wizard references the columns by order, and not by header
name. This causes the model to fail.
If an .lml file is loaded by selecting Open in the File menu or by using the Open file button,
the model settings are not correctly applied (QC 584): If a user loads an .lml file using either
of the above methods, the settings in the Bioequivalence Model wizard are set to their defaults.
However, the settings are correctly saved in the .lml file. The workaround is to open the .lml file
using the Load or Previous Model buttons in the Bioequivalence Model wizard. The settings
saved in the .lml file are correctly applied when the model file is loaded.
Absolute error Bars revert to Relative error bars when a chart is reloaded (QC 797): If a
user creates a chart and sets the error bars to Absolute, closes the Chart Wizard, and opens it
Revision 0 Page 6 of 16 December 2009