PHX WNL QA_13April20.. - Pharsight

Q&A Session
The State-Of-The-Art Software Platform for PK/PD Modeling:
Phoenix ® WinNonlin ® 6.2
General Questions
Q: How can I watch this presentation again?
Once we receive the recording link from WebEx, our web seminar provider, it will be posted on the
Pharsight Archived Events page of our website. The recording will include the entire presentation,
including slides and demonstration. http://www.pharsight.com/events/eventsonline_archive.php
Q: Is there a trial version of phoenix WNL available now on your website?
Evaluations of our software are offered for qualifying organizations. Please contact our sales
department for further information or request an evaluation copy at
http://www.pharsight.com/products/prod_phoenix_winnonlin_order.php
Q: What is the value for on-site training courses?
In general the course is very similar to the public courses but if you have more than 5 attendees then it
is more economical to schedule an on-site course. On-site training courses could be geared towards
interest that a company will particularly have. Pharsight also offers fully customized training but there
might be some additional fees for this type of customization.
________________________________________________________________
Questions about Importing
Q: Can concentration time data be imported directly from Watson LIMS? If so, how is this done?
Phoenix Connect provides the ability to interface using ODBC (Open Database Connectivity). A Watson
LIMS script is included with Phoenix Connect. There is documentation on this in the User’s guide
Chapter 40.

What is New in PHX WNL 6.2?
Q: What's the major difference between 6.1 and 6.2?
A detail explanation of what is new in Phoenix 1.2 is provided in the release notes. Some highlights of
these differences include:
• A new Job Management System to allow for remote execution.
• New IVIVC toolkit 2.0 for Phoenix WinNonlin + Improvements
• License Wizard to facilitate the installation of locked licenses both for nodes and floats
• Support for Windows 7 in 64-bit
• Improvements to workflow diagrams and visualization of results
• Able to export images (non-phoenix native) via Word Export
• New graphic type – Categorical X Plot
• More formatting capabilities for plots:
• Allow formatting (including symbols and subscripts) of the XY plots axes.
• Allow formatting of error bars in XY plots
• Improvements to data tools
• Transforms can now use ‘and’ or ‘or’ logical operators
• Option to autosave projects
• NCA Improvements
• Displays the selected method for lambdaz selection in the output
• Better warnings if user makes unaccepted selection (e.g. tau=0)
• Additional information added to the history tab for NCA objects
• Many improvements to Tables including capability to order and custom sort columns, rows and
descriptive statistics
_______________________________________________________________
IT Questions
Q: Does Phoenix work with 64 bit Windows 7 operating systems?
A: Yes, Phoenix WinNonlin is compatible with Windows 7 64-bit its supported languages are English,
Spanish, German, Simplified Chinese, French, and Japanese as long as the regional settings are set to
English. Please see the Getting Started Guide or the website for product requirements for a complete
listing.
Q: Can you have the old WinNonlin and Phoenix WinNonlin installed at the same time on one
computer?
Yes, this is not a problem between WNL5 versions and PHX WNL 6 versions. However, you cannot have
Phoenix WinNonlin 6.1 and Phoenix WinNonlin 6.2 in the same computer.
Q: How do the existing users of WinNonlin get hold of the Phoenix?
Existing users can download Phoenix WinNonlin 6.2 from our support website at:
www.pharsight.com/support.

Pricing Questions
Q: If I already have WNL5.2.1 how much is it to upgrade to Phoenix?
If you have a current license of WNL you can upgrade to Phoenix WNL for free. If your license is for a
WNL enterprise version you will get PHX WNL and PHX Connect. You can also run WNL5 and PHX WNL
6.2 simultaneously with the same license so I encourage every current user of WNL to download and try
it out. Existing users can download Phoenix WinNonlin 6.2 from our support website at:
www.pharsight.com/support.
Q: How much is Phoenix WinNonlin?
A: The price of Phoenix WinNonlin depends on the type of license (node vs. float) that one purchases.
Node licenses are only for one computer, while float licenses reside on a server and a user checks it in
and out as needed. In other words, users can share a license as long as it is not used concurrently.
There is also different pricing for academia and for bundles (i.e. more than one Phoenix product is being
purchased). To obtain more information about pricing please contact sales@pharsight.com or see the
contact list presented in the slides for each region.
Q: The price of Connect module is definitely too high for what it's worth doing with
Pharsight feels that the value proposition for Connect is high. We will be offering a webinar in May
about PHX Connect that might provide you a better understanding of this powerful tool. We are able to
run programs like R, PsN, XpoSe, NONMEM, S-plus, SigmaPlot as part of a PHX workflow. It also gives
you CDISC import/export capabilities and ODBC capabilities. We will continue to create plug-ins for this
tool that the industry requires and be able to run it under the same Phoenix umbrella.

Documentation Questions
Q: Is there a Glossary of terms used?
Yes, the User’s Guide has a Glossary at the end and for particular objects the output is always explained.
For example, for the NCA output a table of parameters and formulas are provided. A snippet is below
Questions about Functionality
Q: Can you still pre-define decimal place and/or significant figures before calculating PK parameter
estimates?
No, this functionality has been shifted to tables. You can set the decimal place and significant figures in
the tables but it has been removed from the NCA module as it was causing some rounding problems
downstream. One can also copy the worksheet to the data folder and then use the formatting options
there before for example exporting.

Q: How do you use the BLQ tool? Can you use different rules in one model?
Yes, the BQL rule allows you to take data that has been flagged as

Q: I installed 6.2 last week and it looks like I still cannot move tasks in the Object Browser upward or
downward.
This feature was not fixed in the PHX WNL 6.2 version as the underlying work was putting too many
other things at risk but it is in the list of things to work on. The only possible way to do this now is to
create a sub workflow and then move it back. This is not an ideal solution and we are aware of that.
Q: If you are doing a compartmental analysis with data from several subjects, do you simply average
the resulting microconstants calculated separately for each subject?
Yes, this is the most accurate methodology without getting into population modeling. You would also
need to determine which model fits most of the subjects as you should not report different models in
your summaries.
Q: Can the Phoenix project be exported in a format that a client (without Phoenix) access for QA
activities?
Yes, there are several objects. If you want the ‘Full’ project, highlight the main workflow, right click and
select the option of ‘Dependencies’. This will export everything and create an .xml file showing you the
relationships. Also one can download a version of PHX and don’t have a license for it. The projects will
load and display but cannot be re-executed. The dependencies option can be used with every workflow
not just NCA.
Q: For compartmental analysis, what would be the right option to choose (e.g. rat PK study, IV)?
This would depend on your data. You should evaluate the profile in log scale to see how many
compartments are needed and what you know about your drug and if the kinetics are linear in the dose
range given. We suggest that you read the book by Gabrielsson and Weiner (PK & PD Data Analysis –
Fourth Edition) or take one of our training courses.
Q: Can you generate data tables of PK or toxicokinetic data using the WinNonlin software?
The data object in PHX WNL is very flexible and can probably accommodate most of the type of
tabulations that you require. In addition to all the options offered by default (that you can create
templates from) there are 2 ‘Custom Tables’ provided with the software that generate specific layouts
with specific inputs (Bioavailability Statistical Summary and Bioequivalence Demographics). This
information is outlined on Chapter 34 of the User’s guide. Companies that want to build their own
‘custom tables’ would need to create them using XSLT and this will likely require some programming
expertise investment.
Q: Can phoenix WNL do population PK?

No, Phoenix WinNonlin cannot model the between and within variability via a non-linear mixed effect
model. Another Phoenix product Phoenix NLME does population PK and PK/PD. The look and feel of the
2 products is the same but Phoenix NLME offers new objects in the workflow to do population modeling.
Q: If I currently have WinNonlin 5.3, will my existing data be available to view in Phoenix when I
upgrade and is there any conversion process I need to do?
All the data from WinNonlin 5.3 should be able to be loaded in PHX WinNonlin 6.2. However, if you
want the ‘workflows’ in PHX to be built based on WNL5 data then you need to save the WNL5 data as a
workspace (making sure to save the original data in the same folder location prior to saving the
workspace). Workspaces can be loaded into PHX WNL and in addition to loading your data it will also
attempt to build a workflow. Note that if you detached worksheets in WNL5 they will not load correctly.
However, in general you should not have any problems loading legacy data.
Q: Can Phoenix WinNonlin 6.2 be used for Monte Carlo simulation?
No, Phoenix WinNonlin is not designed to perform Monte Carlo simulations. However, Phoenix NLME
product uses monte carlo methods when sampling of random effects during simulations and predictive
checks for population pk/pd models.
Q: Can one customize the output to Word in 6.2? In 6.1 the tables are not well formatted and cover
too many pages.
One the data has been exported to Word the user can edit the tables as Word tables but there is no
customization of output from the Phoenix end except for the options shown. We are working on a
better reporting tool that will alleviate these problems but this will be in the future.
Q: Current, we use AutoPilot. Given the template capability in Phoenix and how easily data can be
map, will Phoenix replaces AutoPilot? Will there be a future AutoPilot version with Phoenix?
No, Phoenix does not replace AutoPilot. AutoPilot gives capabilities to customize output according to
company SOPs that is not easily implemented without AutoPilot (for example, footnotes and application
of specific configurable business rules). There are also a few graphics in AutoPilot that Phoenix WNL
cannot yet create. In other words, AutoPilot compliments Phoenix. A version of AutoPilot (initially for
plasma analyses) that is integrated into Phoenix is planned for end of June / beginning of July.

Q: When import the data from out exls. how to delete the unnecessary information and how to match
the form WNL required?
The import Wizard in Phoenix allows you to indicate the rows to import from an Excel file. I will attach
the phoenix project that was partially shown in the webinar if you want to see some additional details.
You will need to have Phoenix WinNonlin installed even if you don’t have license.
Q: What does Pharsight recommend as calculation estimation: linear up/log down, or other?
I (Ana) can only speak for myself but my opinion is that if you had to pick a default estimation the best
would be the general linear up/log down because it accounts for several bumps on the data and also for
log-estimation on the decay part of the curve which is especially important if the data are considerably
spread out. However, with rich datasets when the data was collected relatively close to each other the
4 methods will give you very similar results and one should just document what was use for
reproducibility but I doubt it would change any major conclusion.
Q: Why does my version number show as 1.0 on my NCA core output? Our QA Dept. is complaining
that it used to be there and is not anymore!
The core output for NCA still shows the core version number 1.0 (right at the beginning). This version
applies to the NCA analysis engine (the “core”), which is unchanged since 2007. The NCA engine is one
of many analysis engines implemented in WNL/PHX WNL. The NCA user interface has changed but the
engines behind it are stable and remain the same. See screenshot
However, we realize that this could be confusing so we have entered a defect to make sure that the
version of the software is shown in this output in the future.
Q: 半 衰 期 是 采 用 消 除 相 的 3 个 点 做 的 吗 ?Google Translation: ‘Elimination phase half-life is the use
of 3 points to do?’

Yes, the default algorithm (best fit) in Phoenix WinNonlin has the requirement that at least 3
points are included for the lambdaz calculation and these points should NOT include Cmax.
These rules can be overwritten by the user if a manual selection is done. I hope we interpreted
your question correctly.
Question about Pharsight Modeling Language
Q: Do you present PML in another separately?
There is no current plan to have a webinar about PML. However, we cover PML writing in all of our
training courses and we provide a specific PML guide. Also the user can use build-in models or graphical
models and the PML code is generated automatically as a starting point. The PML language is probably
closer to C and fairly intuitive. Dan Weiner is also translating his PK/PD Data Analysis book using PML
and we will inform you when this is published. IF you have specific question, please join the forum and
several users are always happy to help. www.pharsight.com\extranet
Q: We don't have this new version installed so don’t know how detail the PML language reference is.
Do you have any book or manual on this topic?
Please contact support@pharsight.com for the topics discussed in the guide. Also Daniel Weiner will be
soon publishing an updated edition of his book ‘Pharmacokinetic & Pharmacodynamic Data Analysis’
(Fifth edition) with all the exercises translated to PML. We will also plan on providing some comparative
documentation between WNL5 language and PML and post it in the forum
www.pharsight.com/extranet but have not had the time yet.
Questions on Validation
Q: Is the Validation Suite output acceptable to auditors, for example FDA, EMEA etc. or should
additional validation tests be performed?
The FDA will not comment on the acceptability of tools used to accomplish computer system validation,
because whether the Validation Suite output is acceptable or not will depend on how a particular user
(i.e., Pharsight customer) uses the Validation Suite application. A user should first define the
requirements for a computer system, e.g., Phoenix WinNonlin 6.2 implemented in a user’s
environment. Then, the user should determine what testing will be accomplished to demonstrate the
satisfactory implementation of the documented requirements. If the Validation Suite test cases will
adequately test the functionality defined in the user’s requirements specification, then no additional
testing would need to be done. But, if there are requirements that are not adequately tested by the
Validation Suite tests, then the user should define and execute additional testing.

Q: What is the cost of the validation suite for current Phoenix users? I have not purchased the
validation suite before
Please contact sales@pharsight.com as every quote is dependent on what you currently have. Note
that the Phoenix Validation Suite can be used to validate many Phoenix products so it would depend on
what is needed and the version.
Q: Will we need to use a new version of the validation suite for Phoenix Connect? If so, when will it
be available?
We are unsure if this question relates to the old WNL Validation Suite where now there are two
validation suites (one for PHX WNL and one for PHX Connect), or if the question relates to
versioning. There are separate Validation Suite products for PHX WNL and PHX Connect, and the
Validation Suite versions are compatible with certain PHX product versions. So, if you want a Validation
Suite for PHX Connect 1.2, you will need to wait for PHX Connect Validation Suite version 1.1, to be
released in the summer.