Phoenix Getting Started Guide
Phoenix Getting Started Guide
Phoenix Getting Started Guide
Guide
Applies to:
Phoenix 8.4
Legal Notice
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Phoenix Installation and Licensing
This section contains installation instructions and licensing information for the Phoenix plat-
form and its modules, such as Phoenix NLME, the IVIVC Toolkit. The generic term Phoenix is
used to simplify terminology.
System and hardware requirements
Installing Phoenix
Post-installation considerations
Silent installation of Phoenix
Phoenix 64-bit versus 32-bit version
Licensing of Phoenix software
Testing the Phoenix installation
Test installation of Phoenix NLME
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Required software
Windows® Installer 3.1 can be downloaded through the Microsoft Update service or by
downloading the Windows Installer 3.1 redistributable from the Microsoft download page.
A PDF reader, such as Adobe Reader, must be installed to access PDF files of various software
documents, such as the Validation Suite report.
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Hardware requirements
Processor
Minimum Requirement: Intel i5 processor 3 GHz
Recommended*: Intel i7 processor 4 GHz
RAM
Minimum Requirement: 8 GB of RAM
Recommended*: 16 GB of RAM
Internal Storage Device
Minimum Requirement: 1 GB 7200 RPM Magnetic HD
Recommended*: 1 GB SSD
*Especially for large datasets and large projects.
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Installing Phoenix
Installing Phoenix
The instructions for installing Phoenix WinNonlin and Phoenix NLME are the same.
Note: To allow Phoenix to correctly process projects created in English locales, standards and
formats must be set to US English. Using the Control Panel, navigate to the Region and
Language settings. Select English (United States) as the format, then click Additional Set-
tings and set the decimal symbol for numbers and currency to be a period (.) and, finally,
set the list separator to be a comma (,).
The following instructions assume that the Phoenix license is installed on the end user’s
local machine. If Server license(s) are being used, Phoenix will need to be configured to
use the Server license(s) after installation of the release. For instructions, please refer to
the “Licensing of Phoenix software” section.
Prepare for a clean install
1. Manually uninstall any version of Phoenix released prior to 8.1 (e.g., on Windows, use
Windows > Settings > Apps & features).
The installer only recognizes and uninstalls Phoenix versions 8.1 or later, earlier versions
are not recognized and must be uninstalled manually.
2. Manually uninstall any plugins that were installed separately from Phoenix (e.g., on Win-
dows, use Windows > Settings > Apps & features).
Folders for these separately installed plugins do not get removed when the previous ver-
sion of Phoenix is uninstalled and will remain in C:\Program Files (x86)\Certara\Phoe-
nix\application\Plugins. Such plugins include: Phoenix Integral Plugin, PKAssist, and
PKSubmit.
3. Copy the license file (lservrc) from C:\Program Files (x86)\Certara\Phoenix\applica-
tion\Services\Licensing to a temporary location.
4. Remove all remaining folders and files under C:\Program Files (x86)\Certara.
Start the installer
1. Extract the ZIP file that contains the installation files.
2. Double-click Setup.exe to run the Phoenix Installation wizard.
Setup.exe detects the operating system and starts the appropriate executable.
If you have a version of Phoenix installed that is 8.1 or later, the installer displays a confirma-
tion dialog to proceed with uninstalling that version.
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Selecting OK uninstalls Phoenix. Follow the instructions to remove the software and then
restart the installer.
The installer also checks for the following:
– the appropriate version of the .NET framework
– the LegacyWNL components and Microsoft Visual C++ components
If any of these requirements are not met, a notification dialog is displayed and the installer
will proceed to install the necessary items. A forced reboot must be done prior to installing
Phoenix. To continue with the Phoenix installation after the reboot, double-click Setup.exe.
Follow installer steps
1. On the Phoenix Setup wizard Welcome screen, click Next to display the Setup Type
screen.
12
Installing Phoenix
The GCC component will be installed to C:\PHSTMinGW64 whether the user retains the
default installation location or selects an alternate location.
3. Press Next to display the Destination Folder screen.
4. Specify a destination folder and press Next to display the Ready to Install screen.
5. In the Ready to Install screen, use the Back button to return to the previous screens to
make any changes to the installation or press Next to continue the installation process.
Once installation is finished, the Completed the Installation of Phoenix screen is dis-
played.
6. To complete the installation, the computer should be restarted. However, if restarting
needs to be delayed, uncheck the Restart now box.
7. Press Finish to close the installer.
Return license file and reinstall plugins
1. Copy your license file back to C:\Program Files (x86)\Certara\Phoenix\application\Ser-
vices\Licensing.
2. Reinstall the plugins that you uninstalled.
For PK Assist customers using Integral, the Phoenix Integral Plugin must be reinstalled
before PK Assist is reinstalled.
If you encounter any difficulties with these steps, please contact Certara Support.
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Post-installation considerations
Configuring Phoenix for international use
Executables to be white-listed
Installed folders requiring read/write permission
Modifying, updating, or removing an installation
14
Post-installation considerations
For operating systems with Regional Language settings set to Japanese, the default Cal-
endar type should be set to Western Calendar (Japanese) in order for .xpt files to be
exported correctly.
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Executables to be white-listed
There are executables that may be flagged/quarantined by different antivirus software. This
can cause Phoenix applications to function improperly or even fail. To avoid these types of
problems, the following items should be included in an exception list for virus protection by
your IT professional.
wnlnca.exe in C:\Program Files (x86)\Certara\Phoenix\application\Plugins\WnlModel-
ing\
Phoenix.exe in C:\Program Files (x86)\Certara\Phoenix\application\
Phoenix32.exe in C:\Program Files (x86)\Certara\Phoenix\application\
ChiDistribution.exe in C:\Program Files (x86)\Certara\Phoenix\application\lib\
TDL5.exe in C:\Program Files (x86)\Certara\Phoenix\application\lib\NLME\Executables\
In addition, the following folders (and their sub-folders) may need to be added to the excep-
tion list:
C:\Users\%UserName%\AppData\Roaming\Certara
C:\Users\%UserName%\AppData\Local\Temp
C:\Users\%UserName%\Documents\Certara Projects
C:\Program Files (x86)\Certara
C:\ProgramData\Certara
C:\PHSTMinGW
C:\PHSTMinGW64
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Post-installation considerations
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Silent installation of Phoenix
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If a user or admin needs to use the 32-bit versions of JQS or JPS they are also
installed as jqs32.exe and jps32.exe. To use the 32-bit versions the services must be
stopped and the 32-bit versions must be renamed to jqs.exe and jps.exe respectively.
20
Licensing of Phoenix software
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Licensing of Phoenix software
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License activation
1. Run Phoenix as an administrator.
a. Right-click the Phoenix icon on the desktop and select Run as administrator.
b. In the User Account Control dialog, enter the administrator login information and
press Yes.
2. Select Edit > Preferences from the Phoenix menubar.
3. In the navigation panel, expand the Licensing node and select License Acquisition.
4. On the right side of the Preferences dialog, select the Online tab.
5. In the Online tab, click Test to check that you have access to the Authentication Server
for online license activation.
If the test is unsuccessful, go to the “Offline activation” section.
6. Copy the entire authentication code given in the email.
7. In the Preferences dialog, paste the copied code into the step 2 text field and press the
Activate button.
A verification pop-up confirming that the activation was successful.
Note: If your machine does not have internet access, or if the Online Activation failed, refer to
the “Offline activation” section.
8. Press OK to close the pop-up verification.
9. Restart Phoenix as a non-administrator user, select Edit > Preferences, and, in the navi-
gation pane of the Preferences dialog, select the License Management node.
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Licensing of Phoenix software
10. Verify that the correct license now appears. Below is an example of a correctly installed
local license:
If the License Management window shows a successfully “Acquired” license, you are done
with the license activation and are ready to use your Phoenix application.
Offline activation
In the Offline tab of the Preferences dialog, click the Email Certara license administrator link
to request a license. Include the following information in the email:
– Your System Lock Code (press the Copy Lock Code button in the Preferences dialog
and paste the information into the email).
– Your order number from the Subject line of your license email (C-0xxxxx)
Certara Licensing will use the System Lock Code to make a license code for your machine,
and email it back. Paste the license code(s) into the field in the Offline tab and press Install.
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License management
The License Management panel in the Preferences dialog allows users to see which license
types are available and acquired.
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Licensing of Phoenix software
Commuter licenses
If a commuter license is available, click Request in the Commuter column.
If the commuter license is acquired, its status is changed to Commuting.
The date the commuter license expires is listed in the Expires column.
To return a commuter license, click Release to release the license.
Press Refresh to update the list of available licenses.
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28
Testing the Phoenix installation
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2. Select the General, System, and Non-loaded tabs to see the review the state of each
plug-in type and to confirm they are started.
3. Press OK to exit the Preferences dialog.
Import a dataset
The dataset Bguide1.dat is used to test key Phoenix functions.
1. Select File > Import, click (Import File icon), or right-click the Data Folder in the
Object Browser and select Import to display the Import File(s) dialog.
2. Navigate to <Phoenix_install_dir>\application\Examples\WinNonlin\Supporting files).
3. Select the file Bguide1.dat and press Open.
The File Import Wizard dialog is displayed. The dialog is used to assign options for how
the data are imported and presented.
4. Press Finish.
The dataset is added to the project Data folder and the worksheet is displayed in the
right viewing panel.
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Testing the Phoenix installation
Create a plot
1. Right the Workflow object and select New > Plotting > XY Plot.
The XY Plot object is added to the workflow in the Object Browser and is automatically
opened in the right viewing panel. The default view of an object is the Setup tab, which
contains all the steps necessary to set up an object.
2. Drag the Bguide1 worksheet from the Data folder to the XY Data Mappings panel.
3. Use the option buttons in the XY Data Mappings panel to map the columns to the con-
texts as follows:
Subject to Group.
Time to X.
Conc to Y.
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XY Plot results:
Create a table
Now use the Bguide1 dataset to test the Table object and its summary statistics function.
1. Add the Table object to the workflow by right-clicking the Workflow object and selecting
New > Reporting > Table.
2. Drag Bguide1 from the Data folder to the Table object’s Main Mappings panel to map
the dataset Bguide1 as the input source for the Table object.
3. Use the option buttons in the Main Mappings panel to map the columns to the contexts
as follows:
Subject to Stratification Row.
Conc to Data.
Leave Time mapped to None.
4. In the Options tab (located below the Setup tab, specify which table type the Table
object is to use by selecting Table 1 - Column Summary by Row Stratification from the
Table Type menu.
5. Check the Page Break on Row Stratification box.
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Testing the Phoenix installation
Text output
The Core output contains the model settings and the same data as the worksheets but pre-
sented in plain ASCII text. If there were errors in the model they would be listed here. Part of
this file is shown below:
…
Model: Plasma Data, Extravascular Administration
Number of nonmissing observations: 12
Dose time: 0.00
Dose amount: 100.00
Calculation method: Linear Trapezoidal with Linear Interpolation
Weighting for lambda_z calculations: Uniform weighting
Lambda_z method: Find best fit for lambda_z, Log regression
Compute Concentrations at: 75
Summary Table
-------------
Time Conc. Pred. Residual AUC AUMC Weight
min ng/ml ng/ml ng/ml min*ng/ml min*min*ng/ml
------------------------------------------------------------
0.0000 0.0000 0.0000 0.0000
5.000 340.3 850.8 4254.
10.00 1914. 6487. 5.636e+04
15.00 2069. 1.644e+04 1.818e+05
20.00 1417. 2.529e+04 3.329e+05
30.00 788.8 3.659e+04 5.983e+05
45.00* 496.4 460.9 35.54 4.623e+04 9.434e+05 1.000
60.00* 372.8 357.2 15.63 5.275e+04 1.279e+06 1.000
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Output data
The NCA object creates seven results worksheets: Dosing Used, Exclusions, Final Parameters,
Final Parameters Pivoted, Partial Areas, Plot Titles, Slopes Settings, and Summary Table.
Selections from the Final Parameters and Summary Table worksheets are shown below.
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Testing the Phoenix installation
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Testing the Phoenix installation
Plots
A total of 12 plots are generated; one for each of two formulations, for each of the six sub-
jects. The first two charts for subject one are shown below.
Worksheet results
The PK Model object’s output worksheets partially include Condition Numbers, Diagnostics,
Dosing Used, Final Parameters, Initial Estimates, Secondary Parameters, and Summary Table.
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The Final Parameters, Secondary Parameters, and Summary Table worksheets are shown
below.
Final Parameters worksheet:
Text output
The Core output text results include all model settings and iterations, including the output
from the worksheets. Any model errors would be listed here. Part of this file is shown below.
…
Listing of input commands
MODEL 3
NVAR 3
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Testing the Phoenix installation
NPOI 1000
XNUM 2
YNUM 3
NCON 3
CONS 1,2,0
METH 2‘Gauss-Newton (Levenberg and Hartley)
ITER 50
INIT 0.25,1.81,0.23
MISS ‘.’
DATA ‘WINNLIN.DAT’
BEGIN
The Settings file lists all the settings used to specify the noncompartmental analysis. Part of
this file is shown below.
…
Main: PK Model.Data.study1
Sort: Subject
Time: Time [hr]
Concentration: Conc [ng/mL]
Carry:
Dosing: (Internal)
Initial Estimates: (Internal)
Units: (Internal)
***** Other Parameters *****
…
PK 3-[PK]
Gauss-Newton (Levenberg and Hartley)
Convergence criteria of 0.0001 used during minimization process
50 maximum iterations allowed during minimization process
Plots
The plot results include Observed Y and Predicted Y vs X, Partial Derivatives Plot, Predicted Y
vs Observed Y, Predicted Y vs X, Residual Y vs Predicted Y, and Residual Y vs X. Some plot
results are shown below.
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Predicted Y vs Observed Y:
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Testing the Phoenix installation
Residual Y vs X:
9. In the Model tab (located below the Setup tab), ensure that:
a. Crossover is selected as the Type of study.
b. Average is selected as the Type of Bioequivalence.
c. R is selected as the Reference Formulation.
10. Select the Fixed Effects tab, located below the Setup tab.
Ln(x) is automatically selected in the Dependent Variables Transformation menu. Do
not change this setting.
11. Execute the object.
Output data
The bioequivalence model worksheet output partially includes Average Bioequivalence,
Diagnostics, Final Fixed Parameters, Final and Initial Variance Parameters, Least Squares
Means, and Sequential Tests. The Diagnostics, Final Variance Parameters, and Sequential
Tests worksheets are shown below.
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Testing the Phoenix installation
Diagnostics worksheet:
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Testing the Phoenix installation
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10. Drag the theopp worksheet from the Data folder to the Main Mappings panel.
The theopp dataset is mapped to the Diagonal model and the study variables xid, dose,
time, yobs, and wt are automatically mapped to the contexts ID, Aa, Time, CObs, and
wt, respectively.
11. Execute the object.
12. Close the NLME Job Status dialog by clicking the X in the upper right corner.
Verify the results
1. Select the Verification tab.
The Verification Results state that the model successfully executed, and that no errors
occurred.
Output data
The model creates 23 worksheet results. Some of the output worksheets are Eta, EtaCovari-
ate, Omega, and Theta. Not all worksheets listed under Output Data contain results.
Confirm the accuracy of some of the output to complete the installation test.
1. In the Output Data, select the Theta worksheet and confirm that the following estimates
are the same (after rounding):
tvKa 1.556
tvV 0.455
tvCl 0.0403
stdev0 0.692
Theta worksheet:
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Testing the Phoenix installation
Eta worksheet:
Plots
Thirty-nine plots are listed in the Plots section. Not all listed plots have results.
1. In the Plot output, select Pop CWRES vs PRED and compare it to the screen shot below:
Text output
The Maximum Likelihood Models object creates six text files. The Settings text file lists
model settings, part of which is shown below.
…
Sort:
ID: xid
Aa: dose
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Time: time
CObs: yobs
wt: wt
…
test(){
deriv(Aa = -Ka * Aa)
deriv(A1 = Ka * Aa - Cl * C)
dosepoint(Aa)
C=A1/V
error(CEps = 1)
observe(CObs = C + CEps)
stparm(Ka = tvKa * exp(nKa))
stparm(V = tvV * exp(nV))
stparm(Cl = tvCl * exp(nCl))
covariate(wt)
fixef(tvKa = c(, 1.54697,))
fixef(tvV = c(, 0.455465,))
fixef(tvCl = c(, 0.0402979,))
ranef(diag(nV, nKa, nCl)=c(0.01809, 0.41265, 0.06997))
}
------------------------------------
id("xid")
time("time")
dose(Aa<-"dose")
covr(wt<-"wt")
obs(CObs<-"yobs")
table(file=”posthoc.csv”, time(0), Ka,V,Cl)
------------------------------------
Run Options
Method: FOCE L-B
N Iter:1000
Input sorted by subject+time
Enabling automatic log transform (if applicable)
ODE solver method: matrix exponent
Method of computing standard errors: Central Diff
Hessian standard errors
Confidence Level %95
Simple run was performed
This concludes the installation test for Phoenix NLME. Close project without saving it.
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Index
I
Install
NLME 11
silently 19
WinNonlin 11
L
License
activation 24
management 26
server configuration 28
N
NLME
installation 11
P
Permissions for installed folders 17
Preferences
license activation 24
license management 26
license server configuration 28
S
Silent install 19
V
Verify
population modeling 47
W
White-listed executables 16
WinNonlin installation 11
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52