What's New in WinNonlin 5.3

What’s New in WinNonlin ® 5.3
Objectives for version 5.3
The WinNonlin ® 5.3 release addresses certain defects and enhancement requests that have
been identified since the release of WinNonlin ® 5.2.1.
This release is the last supported non-Phoenix version of WinNonlin released and represents
Pharsight’s continuing efforts to support our valued customers who have not yet migrated to
Phoenix WinNonlin.
The main objectives for this release are:
• To support WinNonlin on Microsoft Office 2007 as well as Windows Vista and 32-bit
and 64-bit versions of Windows 7; and,
• Provide a number of feature enhancements and fixes within the IVIVC Toolkit for
WinNonlin ® .
This release also includes a small number of other general WinNonlin enhancements and fixes.
A complete list of these is included in the attached release notes and is also available on
Pharsight’s support and download site.
Future releases of WinNonlin will be on the Phoenix Platform. The latest version of Phoenix
WinNonlin® (Version 6.1) was released October 30 th . There is no fee to upgrade to Phoenix
WinNonlin for current WinNonlin users and both applications can be used simultaneously with
the same license until the license expiration date.
What’s new in Version 5.3
Document Manager in Pharsight Knowledgebase Server allows users to delete multiple
items at once (QC 1270): In WinNonlin 5.3, users can delete multiple items at once in the PKS
Document Manager. Previously, users were limited to deleting one item at a time.
The Equation Manager in the Multi-Transform tool expands to match wide column
headers and lengthy cell values (QC 1515): In previous versions of WinNonlin, it was
sometimes difficult to use the Equation Manager because the grid view displayed fixed column
widths which could result in the inability to see full column names or cell contents. The column
widths of the grid displayed in the Equation Manager now match the column width or data
values found in the selected worksheet, whichever is longer, up to approximately 64 characters.
Annotation column cells in workbooks now wrap text (QC 1776): In WinNonlin 5.3,
workbook annotation column cells wrap text so long descriptions are easier to read. Loading
workbooks created in earlier versions of WinNonlin will also display these Annotation columns
with the new wrap text formatting.
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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

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.
Copyright© 2009 Certara Page 4 of 4 December 2009