Release Notes - Pharsight

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WinNonlin ® 5.3 Release Notes Known issues in Version 5.3 Re-attach, WinNonlin gives two error messages and the table disappears and cannot be recovered. Linear Mixed Effects Wizard crashes when stress testing is done using very long string values (QC 2478): If a user decides to perform stress tests on WinNonlin's Linear Mixed Effects engine, then any test data sets cannot contain very long string values. Table Wizard incorrectly rounds decimal places in individual data before calculating summary statistics (QC 2479): The Table creation function in WinNonlin only accurately supports 10 significant digits or decimal places. If any values used in table creation contain more than 10 significant digits or decimal places, then the extra digits or decimals places are truncated before summary statistics are calculated. For example, if there is a value where the integral portion is 4 digits, the decimal places are only accurate to 6 digits, and if the integral portion is 7 digits, the decimal places are only accurate to 3 digits. Pharsight ® Knowledgebase Server scenarios with multi-transformed workbooks from which NCA models are derived might cause an error in PK Automation projects (QC 2480): In some cases, the sort keys of the multi-transformed data set do not match the sort keys in the derived NCA model. When the model is saved locally, WinNonlin is unable to reset the sort keys of the data set so the model cannot run. Attempting to use the model with the data set in an automation project gives the following error message: An error has occurred in the application. Failed to Load Scenario via scripting. The workaround is as follows: • Open the model in WinNonlin. • Open the data variables for the model and click OK. • Click on the Model workbook and select Sort in the WinNonlin Tools menu. This shows the sort keys for the workbook. They should match what is in the model. If they do not match, then change the workbook sort keys to match the model sort keys. • Click OK. • The NCA output workbooks turn pink. Refresh them or re-run the model. • After a successful modeling run, save the scenario back into the Pharsight Knowledgebase Server, In the WinNonlin File menu, select Save or Save As. Table Wizard refreshes cause incorrect formatting or table creation failure when two or more tables are created from the same data set (QC 2482, CRM 65100, 61552): If two tables are created using the same data set and the data set is changed, then refreshing the tables causes the tables to become incorrectly formatted, or the refresh fails to create a new table. The workaround is to close the Table Wizard before selecting to refresh the tables. WinNonlin can lose the scenario hierarchy in the Pharsight Knowledgebase Server Load dialog (QC 2484): If a user logs in to the Pharsight Knowledgebase Server, selects a study that has multiple daughter scenarios, loads the study, and clicks Cancel in the Select the fields for the Observation worksheet dialog, the study's scenario hierarchy is flattened. Revision 0 Page 14 of 16 December 2009
WinNonlin ® 5.3 Release Notes Known issues in Version 5.3 Saving a workspace should automatically save a copy of the loaded workbook in the same folder but it does not (QC 2487): If a user saves a workspace, then WinNonlin should automatically save a copy of the loaded workbook in the same directory. However, WinNonlin saves a pointer to the data and not the actual data in the workspace, which causes confusion for users when they try to share work. The workaround is to place a copy of the data in the same directory as the workspace file, or warn other users that the workspace file contains a pointer to the data and not the actual data. Manual edits to a chart previously saved in the Pharsight Knowledgebase Server do not persist when the chart is saved back into the Pharsight Knowledgebase Server (QC 2488): If a user makes changes to the X-axis or Y-axis labels of a chart using the Chart Designer, for example, the chart is displayed correctly in WinNonlin, even after the chart is saved to and loaded from the Pharsight Knowledgebase Server. However, when the same chart is inserted into PKS Reporter using either the Insert Multiple PKS Images or the Insert PKS Tag operations, the chart defaults to the labels used before the user changes were made. This defect also affects other chart attributes modified in the Chart Designer. Changing the Data Variables selections in NCA model 220 resets Slope 2 to Best Fit (QC 2499): This defect occurs when a user specifies the start and end times for Slope 2 in NCA model 220, and then changes the selections made in the Data Variables dialog. After the changes are made in the Data Variables dialog, Slope 2 is switched back to Best Fit instead of using the user-specified values. A problem reading the dosing worksheet prevents any analysis in an NCA Constant Infusion model (QC 2504): The dosing sheet for a mixed matrix (plasma and urine) study is not initially read correctly by WinNonlin, even if a matrix is excluded. The result is that a single failed profile prevents the other profiles from being analyzed. The workaround is to choose to not default to PKS dosing by selecting the Dosing Data Variables dialog in the Model menu. This allows the user to select a different dosing data worksheet. Clear the No Source check box and then select the dosing data from another worksheet. A user can then enter dosing data manually, or select a transformed dosing data worksheet as the source. Missing values are not grayed out in the NCA Final Parameters and Summary Table worksheets (QC 2505): Missing values are not grayed out in the NCA Final Parameters and Summary Table worksheets, and there are inconsistencies in how the worksheets display some missing values. For example, a missing value in the Final Parameters worksheet is sometimes displayed as a zero in the Summary Table worksheet. Certain values in the terminal phase of the Nonparametric Superposition Wizard should not permit superposition but the analysis completes anyway (QC 2506): If a user selects the Define terminal phase check box and enters a limited range of values so that the terminal phase contains only one point, the terminal phase cannot be determined. However, the Nonparametric Superposition Wizard runs anyway. Revision 0 Page 15 of 16 December 2009
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Release Notes - Pharsight

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