Using WinNonlin®

The following example outlines the use of WinNonlin® to summarize data from a two-period crossover study, using non-compartmental analysis.

Load Data

WinNonlin can open a variety of data file formats, including SAS XPORT, Excel and ASCII text. WinNonlin Enterprise can load data directly from the Pharsight® Knowledgebase Server™ (PKS™) or any ODBC-compliant database, such as Oracle or a LIMS system. Data opens into a spreadsheet-like workbook.

profiles pwo

Data Exploration and Preparation

Once open in WinNonlin, study data may be sorted and transformations or field code replacements performed if needed. Profiles that will not be analyzed should be excluded. Often, it is useful to plot the data to explore its shape, using the WinNonlin Chart Wizard.

timeconc

Analysis

This example uses noncompartmental analysis to summarize time-concentration profiles for six subjects in each of two study periods. WinNonlin NCA model 200, representing extravascular dosing for plasma data, is loaded via the WinNonlin PK/PD/NCA Analysis Wizard.

modelwiz

Model variables, dosing, and analysis and output options are set using a series of intuitive dialog boxes.

dosereg

Results

One button click runs the analysis, generating tabular and optional text and plot output.

ncaworkbk

Summarizing the Results

In this case, descriptive statistics are calculated to summarize PK parameters across subjects.

dstats

Reporting

Any or all results may be copied and pasted into reports, saved to PKS for use in PKS Reporter, or exported directly to Microsoft Word®, as done here.

wordexport exportresult

Saving and Updating the Analysis

Input data, analysis settings, and output can be saved together as a WinNonlin workspace. WinNonlin Enterprise can save analysis settings, results as well as associated documents such as scripts or reports to PKS for secure storage, quick retrieval, change tracking and version control.

WinNonlin remembers the relationships among input data and analysis outputs. Output can be refreshed automatically to reflect any changes to the input data or analysis settings, using WinNonlin’s Refresh feature. In WinNonlin Enterprise, the updated analysis and output can be saved to PKS as a new version of the same analysis scenario.