FAQ

We list here the questions regarding the use of PKanalix when everything runs fine. If you have an issue with download, installation, run and display, please check Frequent installation issues.

If you think there is a bug in one of the MonolixSuite apps, please check if it is already in our List of known bugs, and otherwise write us at support@lixoft.com.

Regulatory

• Are NCA and CA analyses done with PKanalix accepted by the regulatory agencies like the FDA and EMA?  Yes.

• How to cite Monolix, Simulx or PKanalix? Please reference each application as here (adjusting to the version you used):

Monolix 2024R1, Lixoft SAS, a Simulations Plus company
Simulx 2024R1, Lixoft SAS, a Simulations Plus company
PKanalix 2024R1, Lixoft SAS, a Simulations Plus company

Running PKanalix

• On what operating systems does PKanalix run? PKanalix runs on Windows, Linux and MacOS platform. The requirements for each platform can be found on our download page.

• Is it possible to run PKanalix in command line? It is possible to run PKanalix from the R command line. This complete R API provides the full flexibility on running and modifying PKanalix projects with R functions.

Input data

• Does PKanalix support sparse data? Yes. Starting from the version 2024R1, PKanalix has a Sparse data NCA feature.

• Does PKanalix support drug-effect or PD models? It is possible to use custom models in CA, and PD models are available via built-in model libraries. However, a time column is required in the dataset.

• What type of data can PKanalix handle? Extravascular, intravenous infusion, intravenous bolus for single-dose or steady-state plasma concentration and single-dose urine data can be used. See here.

• Can I give the concentration data and dosing data as separate files? Yes, this is possible with the data formatting module.

• Can I give the dosing information directly via the interface? Yes, this is possible with the data formatting module.

• Can I have BLQ data? Yes, see here.

• Can I define units? Yes, see here.

• Can I define variables such as “Sort” and “Carry”? Yes, check here.

• It is possible to define several dosing routes within a single data set? Yes, check the ADMINISTRATION ID column.

• Can I use dose normalization to scale the dose by a factor? Yes. In PKanalix 2023R1, the amount can now be specified in mass of the administered dose per body mass or body surface area.

Settings (options)

• How do I indicate the type of model/data? Extravascular versus intravenous is set in the Settings window. Single versus steady-state and infusion versus bolus are imputed based on the data set column-types.

• Can I exclude data with insufficient data? The “Acceptance criteria” settings allow the user to define acceptance thresholds. The result tables can then be filtered in the interface according to these acceptance criteria.

• Can I set the data as being sparse? No, sparse data calculations are not supported. If supporting sparse data is important for you, please let us know so that we take it into account for future versions.

• Which options are available for the lambda_z calculation? Points to be included in the lambda_z calculation can be defined using the adjusted R2 criteria (called best fit in Winonlin), the R2 criteria, a time range or a number of points. In addition, the a specific range per individual can be defined, as well as points to include or exclude. Check the lambda_z options here and here.

• Can I define several partial areas? Yes.

• Can I save settings as template for future projects? Not as such. However, the user can set the data set headers that should be recognized automatically in “Settings > Preferences”. Moreover, browsing a new dataset in a given project keeps the calculation settings that are compatible with the new dataset.

• Do you have a “slope selector”? Yes, check here for information on the “Check lambda_z“.

• Can I define a therapeutic response range? No.

• Can I set a user-defined weighting for the lambda_z? No. But most common options are available as a setting.

• Can I disable the calculation of lambda_z (curve stripping in WinNonlin)? Yes, Lambda_z can be removed from the list of parameters to compute.

Settings (output results)

• Can I change the name of the parameters? Yes, in the preferences of PKanalix (since 2023R1 version), you can rename NCA parameters as you wish. The output files will contain both your custom names and CDISC names.

• Can I export the result table? The result tables are automatically saved as text files in the result folder. In addition, result tables can be copy-pasted to Excel or Word using the copy button on the top right of the tables.

• Can I choose which parameters to show in the result table and to export to the result folder file? Yes, see here.

• Are the calculation rules the same as in Winonlin? Yes.

• Can I define myself the result folder? By default, the result folder corresponds to the project name. However, you can define it by yourself. See here to see how to define it on the user interface.

Results

• What result files are generated by PKanalix? When running a task like NCA, CA or BE, results are automatically generated (one output file per table) in a result folder, and displayed in the RESULTS tab. Plots are also automatically generated and displayed in the PLOTS tab.

• Can I replot the plots using another plotting software? Yes, if you go to the menu Export and click on “Export charts data”, all the data needed to reproduce the plots are stored in text files.

• When I open a project, my results are not loaded (message “Results have not been loaded due to an old inconsistent project”). Why? When loading a project, PKanalix checks that the project (i.e all the information saved in the .pkx file) being loaded and the project that has been used to generate the results are the same. If not, the error message is shown. In that case the results will not be loaded because they are inconsistent with the loaded project.

Reporting

• Can I generate a report? Yes, starting from PKanalix 2023R1, automated report generation is possible.

• How can I include plots and table from different PKanalix projects into the same Word document? It is currently not possible to include plots and tables coming from different PKanalix runs into the same Word document in one step. You can add placeholders to an already generated report and use it as a template for another project, however we are aware that this is not a very convenient solution. If generating a single report for several projects is important for you, please let us know so that we take it into account for future versions.

• The report I generated via command line or via R do not contain plots. This is a known limitation of the current implementation of the reporting feature. If generating reports with plots from R or from the command line is important for you, please let us know so that we take it into account for future versions.