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WinNonlin Validation Suite
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WinNonlin® Validation Suite™ provides the following tests. Any or all can be included in a validation run. The suite of tests covers all major WinNonlin functions and options, including chart, text and workbook output.

  • General_Functionality: Tests charts (bar and scatter plots), data formatting and precision, data manipulation, data dependencies, chart export to PCO, BMP, data export to PWO and SAS Transport files, and data import from Excel, SAS Transport and NONMEM formats.
  • MM_Models : Fits test data to each of WinNonlin’s Michaelis-Menten models and compares results against expected output.
  • NCA_Modeling : Summarizes test data using each of WinNonlin’s noncompartmental analysis “models” and tests against expected output. Tests include urine and plasma data, parse and rich sampling methods, data with missing and excluded values, with and without sort variables, and cover a range of NCA settings.
  • PD_Models : Fits drug effect data to each of WinNonlin’s compiled pharmacodynamic models and compares results against expected output.
  • PK_Models : Fits time-concentration data to each of WinNonlin’s compiled pharmacokinetic models and compares results against expected output. Several models are fit using each of microconstants and clearance parameterization (PK models 1, 3, 4 and 7).
  • PK_PD_Models : Fits drug effect data based on effect site concentrations generated from blood concentration data, using WinNonlin’s PK/PD link model with PK model 1 (IV bolus, first-order elimination) and PD model 101 (simple Emax), and compares the results against expected output. The link model treats the pharmacokinetic parameters as fixed, and generates concentrations at the effect site to be used by the PD model. The model is fit using the compiled model and a command file.
  • Linear_Models : Verifies the functionality of the linear models (added in WinNonlin 5.2).
  • Table_Templates : Verifies that WinNonlin table templates 1-8 function correctly. Table template 9 should be tested manually.
  • Toolbox_Functions : Verifies that the following WinNonlin tools operate correctly: Crossover Design (using each of separate and stacked input data columns), Deconvolution, Descriptive Statistics, LinMix (all options), Merge, Bioequivalence (average, population and individual), Semicompartmental Modeling, and Nonparametric Superposition.
  • WinNonlin_Installation_Qualification : Verifies that all files required by WinNonlin are installed at proper locations in the test machine.
  • WNL_Examples : Runs 21 modeling and noncompartmental analysis examples from the WinNonlin Examples Guide.

 

Note: The WINNONLIN COMPUTATIONAL VALIDATION REPORT.PDF, on the product CD, contains details on the reference output used as a basis for validation.