Release Notes - Pharsight

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WinNonlin ® 5.3 Release Notes Known issues in Version 5.3 Loading a saved Multi-transform causes information about worksheet to be lost (QC 2396): Worksheet name is lost. Users are not warned when non-refreshable actions are performed on derived output (QC 2481): WinNonlin® does not warn users that when data exclusions and inclusions are performed on derived output, the changes are not preserved when the model that created the output is rerun. The workaround is to use Multi-Transform to exclude or include data in order to retain changes when the model is re-run. Study and scenario status is not displayed in the Pharsight® Knowledgebase Server Load from WNL dialog description window (QC 2493): Currently the only status message displayed in the description window is whether or not the study or scenario is locked. If the study or scenario is unlocked, there is no message stating such in the description window. NCA sparse sampling models are not correctly saved as .pmo files (QC 2523): If a sparse sampling model is run without being saved, then the output workbook does not contain any subject data. If the model contains sort variables it is saved correctly. If the model contains sort variables, then the output from a newly created model and the output from a saved .pmo file are the same. The defect occurs when no sort variable is selected in the model. An error occurs when table template 9 is selected and a user drags variables from one dataset to another (QC 2526): When a user selects table template 9, and attempts to drag variables from the DS1 - Cross Variables box to the DS2 - Variables box, an error occurs that prohibits the user from creating the table. Tables cannot display units in the output if the data set in focus does not have units (QC 2529, 2530): Table templates 1 through 9 cannot display units in the output if the data set in focus does not have units. The workaround for table templates 1 through 8 is to make sure that the data set you want to use is in focus. There is no workaround for table template 9. Extra NCA parameters are generated in output when running a previously saved steadystate model (QC 2538, CRM 63147, 128333, 128613): The problem occurs when an NCA model is applied to a dataset, the steady-state option is set on the Dosing tab of the Model Properties dialog, and the model/data combination is saved as a PMO file or saved as a scenario to PKS. In these cases, when the PMO or scenario is reloaded into WinNonlin and executed, there are unexpected parameter values that will appear on the Final Parameters and Nontransposed Final Parameters worksheets of the derived output. In addition, accessing the Model Properties dialog after loading such a PMO or scenario will result in an error message box that states "Unable to load NCA preferred parameters. Invalid cell reference." Loading LML file at LinMix / Bioequivalence wizard can take a long time (QC 2542): WinNonlin allows users to load LML files from the LinMix / Bioequivalence dialog as a method to reuse the same model settings across various datasets. This process however can take a very long time if the LML file used has data embedded directly in the file. To work around the Revision 0 Page 10 of 16 December 2009
WinNonlin ® 5.3 Release Notes Known issues in Version 5.3 problem, open the LML file in a standard ASCII text editor, and remove the line that has the command "INFILE", and also remove all of the rows of data that follow the command. All other commands should be left intact. Save the changes and then the LML file is ready to be reused on other datasets without causing unnecessary processing delays. Weighting options are lost if the Data Variables dialog is opened (QC 2544): If the Data Variables dialog is accessed for any model type in WinNonlin, the Weighting scheme will always revert back to the default setting of Uniform Weighting. The workaround is to set the Weighting scheme on the Model Options dialog after all Data Variables settings have been made. Table significant figures drop trailing zeroes in some instances (QC 2553, CRM 65517): Depending on the magnitude of the data processed and the precision requested, the Tables module might remove significant digits that are trailing zeros. WinNonlin crashes if a user creates a new workbook and selects Multi-transform (QC 2585): If a user creates a new workbook and selects Multi-transform, WinNonlin displays an error message that states "Runtime Error '380' Improper Property value." At this point users can only click OK to close WinNonlin. In rare instances, profile data is excluded in the NCA Summary Table worksheet (QC 2587, CRM 128348): When this error occurs, the profile data for the last time point for that particular profile is excluded in the Summary Table worksheet. In order for this highly infrequent defect to occur, the input data set must have excluded profiles. NOTE: this is likely to happen when there are exclusions and NO OBSERVATIONS AT TIME 0. If the relative actual time is negative at relative nominal time 0, then WinNonlin throws out those points and generates a row for time 0. This means there are no corresponding carry alongs at time 0, thus the missing values. Therefore the sort keys are shown to be excluded in the Summary Table. Workaround: If users encounter this issue, they can use the Multi-Transform tool to remove the data to be excluded in a systematic and reproducible fashion. Users with a WinNonlin professional license and an AutoPilot PKS license can use AutoPilot to access Pharsight Knowledgebase Server (PKS) (QC 2588): Users must have a WinNonlin enterprise license to access PKS. However, users who have an AutoPilot PKS Edition network license and a WinNonlin professional local license can use AutoPilot to load scenarios from and save scenarios to PKS. However, users with this configuration cannot access PKS from within WinNonlin. User-defined Lambda_Z range not valid for a urine NCA model (QC 1876, CRM 48705): If a data set has a repeating decimal, such as .33333333, then the NCA urine model might not accept a user-defined Lambda_Z range. Revision 0 Page 11 of 16 December 2009
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Release Notes - Pharsight

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