What's New in WinNonlin 5.3

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Validation and prediction grids are now saved as separate workbooks (QC 1850): To improve compatibility with PKS Reporter, the IVIVC Wizard in WinNonlin 5.3 creates two new workbooks using the output in the validation and prediction grids in the IVIVC Wizard. The new workbooks are called "Validation Errors.pwo" and "Prediction Errors.pwo." Descriptive Statistics and the Table Wizard have a new standard deviation option (QC 2407): Users who need to use the 68-95-99.7 rule to calculate standard deviations now have the option to do so in WinNonlin 5.3. The Descriptive Statistics module and the Table Wizard now have a Number of S(standard)D(deviations) option. Also, the Descriptive Statistics module creates new confidence interval output, which is listed in the User’s Guide. IVIVC Wizard creates two new plots during deconvolution process (QC 2429): In WinNonlin 5.3, the IVIVC Wizard creates two new deconvolution plots, "Fa-Avg" and "Fa-Avg By Profile." Fa-Avg is Fabs (subject * formulation) grouped by subject with Fabs_avg (formulation) overlaid vs. time, and sorted by formulation. Fa-Avg By Profile is Fabs grouped by formulation vs. time, and sorted by profile. NOTE: If a user selects a data set that is already deconvolved and averaged, then these plots are not created. The IVIVC Wizard creates a new plot during the correlation phase (QC 2431): In WinNonlin 5.3, the IVIVC Wizard creates a plot showing Fdis vs. Fabs grouped by formulation. This new plot is called "Corr Abs vs. Diss." IVIVC correlation may be validated using mean-observed data (QC 2432): WinNonlin 5.3 provides the option to calculate IVIVC %PE_AUC and Cmax values during the validation and prediction phases using predicted vs. mean-observed concentration-time data where arithmetic means are generated directly from the user-supplied observed data. WinNonlin 5.3 supports Microsoft Windows Vista (QC 2557): WinNonlin now supports the 32-bit version of Windows Vista. WinNonlin 5.3 supports Microsoft Office 2007 (QC 2574): WinNonlin now supports Office 2007. WinNonlin 5.3 uses the same licensing system as Phoenix 1.x (QC 2576): Earlier versions of WinNonlin were using version 6.0 of the Sentinel license management system. WinNonlin 5.3 has been upgraded to use the same version as Phoenix 1.x, namely 8.1.1, of this system. WinNonlin 5.3 supports Microsoft Windows 7 (QC 2578, 2582): WinNonlin now supports 64- bit and 32-bit versions of Windows 7. WinNonlin 5.3 supports increased character names for study data (QC 2579, 2580): To support upcoming PKS 4.1 compatibility, WinNonlin supports using 40 character analyte names, 50 characters route names, and 100 character formulation names. Shorter names are still supported by WinNonlin accessing versions of PKS prior to 4.1. Copyright© 2009 Certara Page 2 of 4 December 2009
Users can save IVIVC projects to PKS when the IVIVC wizard is open (QC 2581): In WinNonlin 5.3, users can save IVIVC files to PKS, including the .ivc project file. Previously, users could not save IVIVC projects to PKS when the IVIVC wizard was open. Now users can save scenarios to and load scenarios from PKS with the wizard open. This allows users to save IVIVC projects to PKS without saving them to a local disk first, thereby maintaining FDA 21 CFR Part 11 compliance by creating a complete audit history for IVIVC projects. Defects corrected in Version 5.3 Missing values in a data set affected KS_pvalue in Descriptive Statistics (QC 2486): In previous versions of WinNonlin, if a user performed descriptive statistics on a data set that had no zero or negative values, and if missing values were added to the data set, then the KS_pvalues changed when the output worksheet was refreshed. This is corrected in WinNonlin 5.3. Previous versions of WinNonlin required manual inclusion of registry entries so SSL (Secure Sockets Layer) would work (QC 2519): To get SSL in WinNonlin versions 5.0 through 5.2.1 to work properly, users had to update the registry settings for both httpstream3 and httpstream4. This problem is corrected in WinNonlin 5.3, so users no longer have to take extra steps to get SSL to work. WinNonlin froze when saving a PWO file (QC 2535): This problem could occur when using WinNonlin after installing a new print driver. WinNonlin 5.3 corrects the problem by forcing an update of the file TTF16.OCX when WinNonlin is installed. NOTE: If a computer has PKS Reporter installed and WinNonlin 5.3 is used to remove a preexisting version of WinNonlin but is not re-installed, PKS Reporter is rendered inoperative. To correct this, install WinNonlin 5.3 on the computer. Table Wizard incorrectly sorted text cross variables (QC 2537): If a column containing text was selected as a cross variable, the Table Wizard did not correctly create the table. This is corrected in WinNonlin 5.3. Numeric subject IDs were incorrectly sorted and plotted by the IVIVC Wizard (QC 2545, CRM 64300): In previous versions of WinNonlin, the IVIVC Wizard sorted numeric subject data as text, so subjects 01 and 11 would be displayed before 02. This is corrected in WinNonlin 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. Copyright© 2009 Certara Page 3 of 4 December 2009
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What's New in WinNonlin 5.3

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