monolix Suite 2023R1 (x64)

[FaridKhan]

monolix Suite 2023R1 (x64)

177.75 MB | | |

x64 | File Size: 193 MB

Description
Lixoft develops modeling and simulation software for advanced model-based drug development. Its products offer powerful and easy solutions for population analysis in pre-clinical, clinical trials and in treatment individualization.

Lixoft's technologies are the result of a ten years research program in statistics and modeling, led by Inria on non-linear mixed effect models for advanced population analysis, pharmacometrics, pre-clinical and clinical trial modeling & simulation.

PKanalix is a user friendly and fast application for compartmental and non-compartmental analysis (NCA)

Very intuitive interface
PKanalix can be used via a graphical interface to easily define settings and rules, check the calculations and display the results. It can also be used via R for powerful scripting.

Straightforward NCA
PKanalix calculates NCA parameters with industry-standard methods, and automatically generates a full set of plots to visualize the data, the distributions of calculated parameters and correlations with covariates.

Reliable and clear results
All results are available as tables and summaries, and as interactive plots for a fast and intuitive interpretation. All settings are saved in the project for reproducible results, and the integrated validation suite ensures correct installation and calculation.

Compartmental analysis
Calculation of the parameters in the Compartmental Analysis framework is also proposed with a large library of PK models. In addition, it includes a direct link toward population modeling using Monolix.

Monolix, the best tool for Model Based Drug Development
Monolix is the most advanced and simple solution for non-linear mixed effects modeling (NLME) for pharmacometrics. It is based on the SAEM algorithm and provides robust, global convergence even for complex PK/PD models. Monolix is used for preclinical and clinical population PK/PD modeling and for Systems Pharmacology.
Monolix enjoys a large user community. Monolix is widely used by academia, the pharmaceutical industry as well as the US regulatory agencies.

Advanced Statistical Methodologies
Reliable convergence for all type of data is a centerpiece in population PKPD modeling, which is why Lixoft pioneered in collaboration with Inria the SAEM algorithm.

Automated generation of diagnostic tests
Monolix automatically generates a full set of diagnostic plots even for complex PK/PD models. For example, you can instantaneously create the Visual Predictive Check, split by any patient subgroup you would want to investigate.

Increased productivity and quality
Efficient C++ solver package, standardized model language with Mlxtran, PK/PD model library and integrated software all contribute to better productivity and quality.

Very easy to use with its GUI
Our solutions are designed for ease of use. Monolix can be used via a graphical interface or command lines for powerful scripting. This means less programming for you and more focus on exploring models and pharmacology to deliver in time to your customers.

Key features
-Continuous, categorical, count and repeated time to event data.
-Mixture models and mixtures of models.
-Inter-occasion variability with any number of levels.
-Proper handling of BLQ data.
-Normal, lognormal, logit, probit and user defined distributions for the individual parameters.

Simulx is an easy, efficient and flexible application for clinical trial simulations

Very easy to use with its GUI
Our solutions are designed for ease of use. Simulx can be used via a graphical interface. This means less programming for you and more focus on exploring different treatments and effects of model parameters on a typical individual and/or simulating a clinical trial using a population of individuals in one or several groups with specific treatment or features. All the results are plotted and easy interpretable.

Amazing flexibility
The interface allows an amazing flexibility to be able to simulate any scenarrii. You can define any population, any treatment, any configuration in a few clicks. Clinical trial design has never been so simple.

Advanced Statistical Methodologies
Outcomes and endpoints can be defined in the dedicated section. It provides a simple and efficient comparison between groups in the good statistical framework.

Increased productivity and quality
Efficient C++ solver package, standardized model language with Mlxtran, PK/PD, TMDD, . model libraries and integrated software all contribute to better productivity and quality. You can make your simulation from scract or use a Monolix project.

System Requiremens
-Architecture: 64 bits
-Operating system: Windows 7, Windows 8, Windows 10, Windows 11, Windows server 2012, Windows server 2016, Windows server 2019, and Windows server 2022.
-1GB RAM or above
-Optimally standard screen resolution not less than 800x600 pixels is recommended.

Whats New
Release Notes MonolixSuite2023R1

This document contains most of the evolution and bug fixes of the software in the 2023R1 version.

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.

Monolix
-[results] Coefficients of variation are reported in addition to standard deviation of random effects in the table of population parameters.
* -data] Sequential approach is now easier since PK parameters from another run can be added as regressors to the dataset directly in the interface (via data formatting module).

monolix Suite 2023R1 (x64)

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