What is PKanalix
Intuitive, efficient and integrated in MIDD workflow
PKanalix calculates NCA parameters with industry-standard methods, and automatically generates a full set of plots and results tables. Reproducibility of results is guaranteed by saving settings in the project, while integrated validation suite ensures correct installation and calculations. And thanks to a direct link to Monolix and Simulx, you can extend analysis to population modeling and explore new scenarios in simulations.
Key Features
Non Compartmental Analysis
The main feature of PKanalix is the calculation of the parameters in the NCA framework. It includes:
specification of calculation methods and acceptance criteria with intuitive settings;
definition of rules for the calculation of the lambda_z –slope of the terminal elimination phase – that can be done via global rules or customized on each individual;
selection of NCA metrics, their ratios and custom parameters to be computed.
Compartmental Analysis
The second feature of PKanalix is the calculation of the parameters in the CA framework. It includes:
selection of a compartmental model using built-in libraries or user-defined custom models;
initialization (with the help of automatic algorithms) of parameters for a better convergence;
specification of calculation methods such as objective function or pool fit option.
Bioequivalence Analysis
The next task in PKanalix compares the average NCA parameters obtained for different groups, e.g. a test and a reference formulations. It includes linear model definition with one or several fixed effected selected in an integrated module. And allows to obtain a confidence interval compared to the predefined BE limits.
Outputs and plots
All NCA, CA and Bioequivalence outputs are displayed in sortable tables and exported in the result folder in a R-compatible format. Interactive plots are also proposed for straightforward interpretation of the results.
Why PKanalix?
Very intuitive interface: Intuitive settings panels, clear definitions of methods, visual tools to check the calculations and personalized display of results – all contribute to a better productivity.
Straightforward NCA & Bioequivalence Studies: Complete workflow - integrated calculation of NCA parameters with industry standard methods and bioequivalence study as recomended by regulatory agencies - is done in a few clicks. NCA analysis has never been so simple.
Reliable and clear results: Publication quality customizable plots, intuitive tables and sortable summaries provide a powerful environment for analysis of results. Includes integrated reporting with customized templates.
Seamless integration for simulations and population modeling: Use the same data and model for all your analysis. Export project in one-click to Monolix for population modeling or to Simulx for simulations of a new dosing regimen.
Reporting: Built-in generation of a report with result tables and plots. Create customized templates and use them in your company for different projects.