PKanalix® is a user-friendly and fast application designed for comprehensive pharmacokinetic (PK) analysis, encompassing compartmental analysis (CA), non-compartmental analysis (NCA), and bioequivalence (BE) studies. It aims to make NCA and CA intuitive, efficient, and seamlessly integrated into the broader modeling and simulation workflow. The software provides a clear user interface with a streamlined workflow for efficient NCA and CA analysis, alongside integrated data formatting and visualization capabilities within its graphical user interface (GUI). It includes a dedicated bioequivalence module designed to meet regulatory requirements. For compartmental analysis, PKanalix offers generalized CA with extensive model libraries and auto-initialization features, enabling fast optimization of CA parameters. The application automatically generates results and plots, providing immediate feedback and facilitating report generation directly from the GUI. PKanalix also features deep interconnection with other MonolixSuite applications, allowing users to export projects to Monolix for population analysis and to Simulx for simulations, ensuring a cohesive workflow across different stages of drug development. Its intuitive interface supports automation via R scripting, enhancing productivity. The platform ensures straightforward NCA and Bioequivalence Studies with integrated calculation of industry-standard NCA parameters and regulatory-compliant bioequivalence studies. Users benefit from reliable and clear results presented in intuitive tables, sortable summaries, and interactive plots, with reproducibility guaranteed by saved project settings and an integrated validation suite. PKanalix facilitates data exploration for initial quality checks and trial overviews through customizable plots. It precisely calculates NCA parameters, allowing flexible definition of λz rules. The bioequivalence task enables comparison of average NCA parameters between groups, providing confidence intervals against predefined limits. For CA, it identifies PK model parameters for individuals using a built-in library and automatic initialization. All outputs are displayed in sortable tables and interactive plots, exportable in R-compatible formats. The R API allows automation of all GUI steps, and seamless integration with Monolix and Simulx optimizes the entire modeling, simulation, and trial design workflow. Comprehensive documentation, examples, and online resources are also provided.

Features & Benefits

• Clear User Interface & Workflow
  • Provides a user-friendly graphical interface with intuitive settings, clear method definitions, and visual tools, enhancing productivity and allowing automation via R scripting.
• Integrated Data Handling & Visualization
  • Offers integrated data formatting, visualization, and automatic generation of interactive, customizable plots and sortable tables for immediate feedback and straightforward interpretation.
• Comprehensive PK Analysis Capabilities
  • Supports Non-Compartmental Analysis (NCA) with flexible λz definition, Compartmental Analysis (CA) using built-in PK model libraries and auto-initialization, and Bioequivalence (BE) studies with regulatory-compliant comparisons.
• Regulatory Compliance & Reliability
  • Ensures calculations meet industry standards and regulatory recommendations, with reproducibility guaranteed by saved project settings and an integrated validation suite.
• Seamless MonolixSuite Integration
  • Directly links with Monolix for population modeling and Simulx for simulations, streamlining the entire modeling, simulation, and trial design workflow by pre-setting parameters.
• Automated Reporting & Scripting
  • Enables automatic report generation from the GUI and offers an R API for powerful scripting to automate repetitive analysis processes.
• Extensive Documentation & Support
  • Provides comprehensive documentation, software manuals, tutorials, and a wide collection of examples, complemented by online resources like webinars and feature highlights.