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WinNonMix® Features

Key features of WinNonMix Professional and Enterprise editions include the following:

  • Nonlinear mixed-effects modeling to support population pharmacokinetic, pharmacodynamic, and PK/PD modeling in a user-friendly software interface
  • Data management via Excel-compatible spreadsheet and workbook files, including support for formulas, functions, transformations, data import/export, missing value codes, sort, merge, and more
  • Extensive library of predefined models and support for user-specified models using the Fortran programming language
  • Equation builder to specify custom models
  • Estimation algorithms for sparse and for rich data sets
  • Optimization methods can use Maximum Likelihood or Restricted Maximum Likelihood
  • Simultaneous fitting of functions and differential equations, including simultaneous PK/PD fittings with different error models
  • Diagnostic and goodness of fit statistics including Akaike’s Information Criterion, Schwarz Bayesian Criterion, and Likelihood Ratio Tests
  • Exploratory data analysis tools
  • Powerful simulation capabilities
  • Descriptive statistics, including weighted descriptive statistics
  • Presentation quality tables and plots, including overlay plots

WinNonMix Enterprise edition offers additional data connectivity:

  • Full integration with the PKS™ Suite of data management, automation and reporting software
  • SQL Query Builder guiding step-by-step creation of SQL queries
  • Custom Query Builder wizard for access to LIMS and other data sources
  • A software development kit (SDK) for your IT/IS staff to use in building and installing additional Custom Query Builder wizards for data management systems not supported by Pharsight®

Supported data sources for the WinNonMix Enterprise include:

  • Any row-oriented data source that has an ODBC driver accessed via the latest version of Microsoft’s® Open Database Connectivity (ODBC) API
  • Remote Oracle databases via an Oracle-supplied ODBC driver and Oracle data connectivity software
  • SAS via a SAS-supplied ODBC driver for both remote and local access
  • Commercial clinical and laboratory data management systems, including LIMS products such as the Watson LIMS system via Custom Query Builder wizards supplied by Pharsight.

Details of specific WinNonMix features follow.

Estimation Algorithms

Two estimation algorithms are available. The linearization method of Lindstrom and Bates computes the Maximum Likelihood or the Restricted Maximum Likelihood, and can be used with sparse or missing data. When using rich datasets, the two-stage estimation method can be used.

Input and Output Data Management

Input and output data is managed via Excel-compatible spreadsheet files. The data interface allows you to create and/or modify WinNonMix data files using formulas and functions. Import and export of ASCII and Excel files, missing value codes, column names, column formats, cut and paste, sort, merge, and powerful editing capabilities are just a few of the features included.

Descriptive Statistics

WinNonMix's Descriptive Statistics allow users to generate summary statistics of variables in input or output grids. In addition to standard descriptive statistics, Geometric mean, Harmonic mean, Mean and Standard Deviation of the logs, Percentiles, and Confidence Intervals are included. WinNonMix also supplies weighted summary statistics. These weighted statistics include mean, standard deviation, standard error, coefficient of variation, confidence interval, and variance.

Analysis of Variance and General Linear Models

ANOVA feature provides the capability to statistically analyze data from crossover and parallel studies.

Graphics

WinNonMix produces presentation quality graphics quickly and easily, with flexible editing and formatting. The charts can be printed to any Windows-supported device, copied into another Windows® application or exported directly to Microsoft Word.

Template-Driven Table Generation

The Tables Wizard makes it easy to create report-ready tabular output. Using templates provided with the system, you can create tables that combine data listings and summary statistics in a variety of formats. Once your table is created, you can easily export or paste it into in a word processing or spreadsheet application such as Microsoft Word or Excel.

Validation and Validation Suites

Pharsight's products, including WinNonMix, are widely used by pharmaceutical companies, academic and research institutions, as well as regulatory agencies. Several of these organizations have audited and approved Pharsight's software and development methods as suitable for use under their GLP, GCP, and GAMP compliance/standards. Pharsight's products are developed using standard, well-documented Software Development Life Cycle (SDLC) processes and procedures, to enable users of Pharsight's products to be GLP/GCP/GAMP compliant. Pharsight systematically validates its products as part of its software development and delivery process.

There is more to being GLP/GCP/GAMP compliant than simply buying well-documented, well-tested, well-developed software. Compliance also requires users to validate the operation of the system within their environment and to use the software properly with written Standard Operating Procedures (SOPs).

 

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