Predict PK output

Output from PK prediction will have a prefix of “Prediction.”

Worksheets

Baseline Stats: Observed summary statistics.

Conv.Exponential Terms: Specified exponential terms and corresponding values for convolution.

Conv.Results: Convolution results.

Model Sim Vitro: Model simulated in vitro input.

Model Sim Vivo: Model simulated in vivo input.

Pred Stats Out: Prediction summary statistics, stacked.

Predicted Stats: Predicted summary statistics for each parameter.

Prediction Errors: Prediction percent error and ratio calculation results.

The following worksheets will have a prefix of “Prediction.Corr Sim.” Refer to the Phoenix WinNonlin Least-Squares Regression Models “Worksheet output” section for descriptions of most of these worksheets.

Correlation Matrix

Diagnostics

Eigenvalues

Dosing Used

Final Parameters

Final Parameters Pivoted

Initial Estimates

Partial Derivatives

Predicted Data

Stacked Partial Derivatives

Summary Table

User Defined Settings

Variance Covariance Matrix

Two sets of the following worksheets are generated and will have a prefix of “Validation.Observed Baseline Nca.” or “Validation.Predicted PK Nca.” Refer to the Phoenix WinNonlin NCA “Results” section for descriptions of most of these worksheets.

Dosing Used

Exclusions

Final Parameters

Final Parameters Pivoted

Partial Areas

Plot Titles

Slopes Settings

Summary Table

Therapeutic Response

User Defined Computed Y

User Defined Parameters

User Defined Parameters Pivoted

Plots

The following plots will have a prefix of “Prediction.” Refer to the Phoenix WinNonlin Least-Squares Regression Models “Plot output” section for descriptions of most of these plots.

Observed Y and Predicted Y vs X: Separate plots are generated for Corr Sim, Observed Baseline Nca, and Predicted PK Nca.

Partial Derivatives Plot

Predicted Y vs X

Weighted Residual Y vs X

Pred Conv Out: Convolution plot of both observed and predicted data (each tab shows plot for one formulation).

Text Files

IVIVC.Prediction.Prediction.Calculate Errors Calculations.PEC: Mappings and option settings for percent error calculations.

Core output: Settings, summary table, and final parameters. A separate file is generated for Corr Sim, Observed Baseline Nca, and Predicted PK Nca.

Settings: Mappings and option settings. A separate file is generated for Conv, Corr Sim, Observed Baseline Nca, and Predicted PK Nca.


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