Release Notes - Pharsight

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WinNonlin ® 5.3 Release Notes Known IVIVC issues in Version 5.3 Certain table options are not retained when the input data set is changed (QC 2548): When users select all three group variable options in the Table Wizard, the option selections are not preserved when the input data set is changed and the table is refreshed. The first two options are available in the File menu in the Table Wizard. The third option is selected by clicking the page break (PB) button. The selections are now retained upon refreshing. The IVIVC Wizard no longer requires the dissolution model to be fit in order to predict PK values (QC 2570): Users can now select their own dissolution data worksheet in the Prediction tab. Users no longer have to fit the dissolution model to predict PK values. WinNonlin encryption updated so automation works with Japanese versions of Microsoft Windows (QC 2583): In previous versions of WinNonlin, people using AutoPilot on a computer running a Japanese version of Windows could not load scenarios from Pharsight Knowledgebase Server because of a password encryption error in WinNonlin. This is fixed in WinNonlin 5.3. PKS Save failure when run with automation (QC 2616): Under system heavy loads, WinNonlin may not be able to save successfully to PKS. The resulting error displayed by the automation application is “Failed to save scenario.” This issue has been corrected in WinNonlin 5.3. Known IVIVC issues in Version 5.3 Performance problem after saving or reloading an IVIVC project that was run up to Build Correlation (QC 1813): Clicking on Build Correlation immediately after loading a completed project creates a performance problem. WinNonlin® can take several minutes or more before getting through the step. Loo-Riegelman Rel_Fraction_Abs output chart displays in wrong scale (QC 1831): If you specify an AUCINF value, the Loo-Riegelman Rel_Fraction_Abs output chart displays in semilog scale, rather than in linear scale. IVIVC Wizard window remains on top of all open applications (QC 1890): If you want to work in other applications while leaving WinNonlin® running with the IVIVC Wizard active, it is suggested that you minimize the entire WinNonlin® parent application to hide the wizard dialog from your desktop. Levy’s chart source is marked as changed after generating UIR or Deconvolve (QC 1991): If you generate Levy Plots outside of the IVIVC Wizard, then use the wizard to generate UIR from the same dataset that was used to create the Levy Plots, after the UIR is generated the two Levy Plot output files change to pink and are marked as Source Changed. Revision 0 Page 4 of 16 December 2009
WinNonlin ® 5.3 Release Notes Known IVIVC issues in Version 5.3 The IVIVC Wizard's Correlation tab and Validation grid do not clear when the input data are changed (QC 2016): If a user loads an IVIVC project that has been run through prediction, and then loads a project that has been run through validation, the Prediction tab of the IVIVC Wizard shows a blank first row in the Prediction grid, along with data loaded from the project that was run through prediction. Also, if the In-Vitro data set is modified after the In-Vitro tab is set up, the Validation grid in the Correlation tab still contains old data. The Validation and Prediction grids should be cleared when a new project is loaded, or when the source data changes, but they are not. The problem is that when a user makes changes in the IVIVC Wizard that clears either of these grids, and then undoes those changes, the Project Status indicator might change to green, but the grids are not re-populated in accordance with the changes. Possible freezing of the IVIVC Wizard when minimizing WinNonlin® or the wizard itself (QC 2180 & 2181): If WinNonlin® is minimized while the IVIVC Wizard is open or the IVIVC Wizard is minimized, the product can become unstable when the Windows Taskbar group for WinNonlin® is clicked to restore or maximize. This problem has only been noted when the Windows Taskbar option to group similar taskbar items is selected. Levy Plot dataset selection doesn't allow for worksheet selection (QC 2211): The workaround is to close the Levy Plots and reopen it. Saving an IVIVC project with a long filename causes Error 53 (QC 2292): If you have a (project name + filename + folder length) combination that nears 128 characters in length, saving an *.ivc project might cause an error. If this occurs, save the IVIVC project to a folder path that is shorter. Unable to load an IVIVC project when the project is moved to another directory and input files are not in same directory (QC 2393): Since IVIVC projects are based on WinNonlin® workspaces, it is highly suggested that input and output files for any IVIVC project be stored together in a unique directory. Doing so ensures that they may be easily moved around on your computer as a group if necessary and shared with your colleagues. Failure to do so may lead to errors occurring. An IVIVC project with a user-defined Tcutoff value fails in the prediction step (QC 2466): If a user enters a Tcutoff of 12 hours when fitting the Correlation, and then clicks the Predict PK button on the Prediction tab, the following error messages are displayed: • Duplicate time values of 12 found in a profile of data for the Input Function on profile: Function=1 • Convolution failed due to all data profiles being invalid. The workaround is to use a custom model. IVIVC Prediction fails when formulations have different numbers of subjects (QC 2469): If the formulations and the mean formulations have a different number of subjects, an IVIVC project fails. Revision 0 Page 5 of 16 December 2009
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Release Notes - Pharsight

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