PHX WNL QA_13April20.. - Pharsight

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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.
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PHX WNL QA_13April20.. - Pharsight

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