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WinNonlin® Features

Key features of WinNonlin® Professional and Enterprise editions include the following:

  • Quick data export to NONMEM®, SAS, S-PLUS®, SigmaPlot® and Excel
  • Extensive built-in library of predefined models
  • Support for user-defined models
  • Easy data management via Excel compatible workbooks, including formulas, functions, data import/export, missing value codes, sort, transformations and worksheet merge
  • One-click export of results, plots, and tables to Microsoft Word®
  • Dynamic memory management for large data sets and complex models
  • Descriptive statistics, including weighted descriptive statistics
  • Units definition and conversions, including the ability to specify preferred output units, units for a dosing regimen, and unit conversions
  • Noncompartmental analysis of both blood and urine data using methods for rich or sparse datasets
  • Three methods of AUC calculation: linear trapezoidal, linear/log trapezoidal, and linear up/log down
  • Support for Excel, SAS Transport, and NONMEM file formats
  • Toolbox functions for deconvolution, semicompartmental modeling, nonparametric superposition and crossover design
  • Automatic determination of initial estimates for most library models
  • Analysis using general linear modeling approaches, including bioequivalence tests as appropriate
  • Built-in scripting language
  • Analysis can be automated or controlled from any VBA-capable tool, such as VB, Word, or Excel

WinNonlin 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 WinNonlin Enterprise include:

  • Any row-oriented data source that has a Microsoft’s® Open Database Connectivity (ODBC) driver accessed via the latest version of 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 WinNonlin features follow.

Noncompartmental Analysis

WinNonlin’s Noncompartmental Analysis (NCA) module computes derived PK parameters (AUC, AUCINF, Cmax, Cumulative excretion, etc.) from blood or urine data. Parameters can be calculated for single-dose or steady-state conditions, for rich or sparsely-sampled data. You can use your mouse to select the terminal elimination phase while viewing a semi-log plot, or let WinNonlin select it for you. Exclusions of individual data points for the estimation of the Lambda Z calculation can also be specified. Area under the curve is calculated using linear, linear/log trapezoidal or linear up/log down rules. WinNonlin also computes partial AUC's even when the endpoints of the desired range are not included in the dataset.

Compartmental Modeling

WinNonlin is a powerful program for the solution of nonlinear regression problems, constrained estimation problems, systems of differential equations, and mixtures of differential equations and functions. Using WinNonlin's simulation capabilities, you can see the effect of different dosing regimens and changes in the pharmacokinetic parameters. WinNonlin's library of models includes PK, PD, PK/PD link models, indirect response models, Michaelis-Menten, and simultaneous PK/PD link models. In addition to selecting library models, WinNonlin allows you to write your own models. WinNonlin supports both ASCII and compiled user models.

Descriptive Statistics

WinNonlin's Descriptive Statistics allows 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. WinNonlin also supplies weighted summary statistics. These weighted statistics include mean, standard deviation, standard error, coefficient of variation, confidence interval, and variance.

Analysis of Variance/General Linear Models

ANOVA/GLM features provide the capability to statistically analyze data from crossover and parallel studies, including unbalanced designs. You can analyze ANOVA, regression and covariance models and calculate both sequential (Type I) and weighted squares of means (Type III). Contrasts, least squares means, parameter estimates and F-tests using user-specified error terms are available. Included is the ability to calculate bioavailability statistics: Anderson-Hauck statistic, Westlake confidence interval, classical confidence interval, power computation, two one-sided t-tests, and ratios of least squares means.

Toolbox

WinNonlin provides a suite of analysis tools called the toolbox: Nonparametric superposition helps to predict drug concentrations after multiple dosing at steady-state. Semi-compartmental modeling is used to estimate effect-site concentrations, given time and plasma concentrations. Crossover design performs nonparametric analysis of 2x2 crossover data. It calculates confidence intervals for each treatment, as well as estimating the relevance of direct, residual, and period effects. Deconvolution is used to evaluate drug release and delivery when data from a known reference input are available that enable specification the unit impulse response (UIR) function.

Graphics

WinNonlin 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.

Scripting Language

The Scripting Language included in WinNonlin Pro and Enterprise provides a batch mode to use for often-repeated analysis and quick and easy re-analysis in response to data changes, as well as comprehensive archival. You can write scripts to help automate the analyses and reports required by your company method sheets.

Input and Output Data Management

WinNonlin input and analysis output data are managed via Excel-compatible spreadsheets. The data interface allows you to create and/or modify 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. 

Validation and Validation Kits

Pharsight's products, including WinNonlin and 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).

Contact Pharsight sales (sales@pharsight.com) about the availability of the WinNonlin® Validation Suite™ to validate WinNonlin in your IT environment.

21 CFR Part 11 Compliance

Pharsight works with customers to help them achieve compliance with 21 CFR Part 11 (Electronic Records; Electronic Signatures; Final Rule) regulations. The Enterprise Editions of WinNonlin and WinNonMix are initial steps toward achieving this compliance, allowing users to read PK/PD data and save analysis results directly to/from any ODBC-compliant database which is protected by user login procedures (such as an Oracle database set up by the customer IT group).

To help achieve full compliance with 21 CFR Part 11, Pharsight has developed a secure research management system designed specifically for the needs of clinical pharmacology and drug metabolism researchers. The PKS Suite uses electronic signatures and audit trails to store and manage PK/PD data and analysis results from WinNonlin, WinNonMix, NONMEM, SAS and other analysis tools.

 

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