Lixoft monolix Suite 2023 R1

NEW FEATURES:

Global interoperability

• Extended interoperability which enables exporting a PKanalix, Monolix or Simulx run to any other application of the MonolixSuite.
  In addition to the exports/imports already available, it is now possible to:
  – export a PKanalix CA run to Simulx to predict how these same individuals would respond to another dosing regimen.
  – export a Simulx run, or Monolix individual fits or VPC simulations, to PKanalix to run NCA on simulated data.

Global display

• A reporting module to generate reports automatically based on a custom Word template file:
  – Placeholders can be written in any Word template file and upon report generation they will be replaced by the plots and tables of a PKanalix or Monolix run
  – Placeholders can be easily generated in the GUI for each plot and table, and then copied into the Word template
  – Placeholders for plots and tables can be customized so they appear as desired in the report
• Custom axis limits can be set for Observed data and VPC plots.
• In the plot Observed Data, trendlines (mean and standard error) can be merged for different groups on the same plot after splitting by a covariate.
• It is now possible to send feedback on the software directly from the interface of any application of the MonolixSuite.

Data set

• A data formatting module in the interface, to make the input format more flexible.
  From an input dataset (not yet in MonolixSuite format), it is now possible to:
  – merge several observation types
  – add censoring information based on BLQ tags
  – add treatment information from an external file or specify it manually with a myriad of possibilities (multidose regimen, repeat cycles, infusions, combined therapies, amount depending on a category, use dose intervals as occasions, etc)
  – add covariate and regressor columns from another file

PKanalix

• [units] Additional normalized units for the amount column, per body weight or body surface area.
• [CA task] The possibility to use any model in CA, self-written in mlxtran syntax or from one of the MonolixSuite libraries.
• [CA task] Improved algorithm in CA to escape better local minima and improve the fit (important for more complex models than standard pk).
• [CA task] New cost function based on Generalized Least Squares which enables to compare models with AIC and BIC.
• [CA task] New weighting option 1/|Ypred*Yobs|.
• [CA results] Individual cost is reported in the individual parameters table, and a new Cost tab shows the value of the global cost, -2LL, AIC and BIC.
• [CA plots] For CA, new Observations vs predictions plot to diagnose the fit.
• [results] Additional summary metrics geometric CV and harmonic mean.
• [preferences] Custom aliases for NCA parameter names and summary metrics names, which appear in the tables, plots and in the report.