Phoenix NLME validation tests

The Phoenix NLME Validation Suite provides automated tests to validate local execution of Phoenix NLME functions and options, including PK, PD, PKPD, and Indirect modeling and data manipulation. Following an automated test run, the Phoenix NLME Validation Suite generates a report that details the tests and results.

For a complete list of tests, see “NLME test cases”.

The three base tests include an installation test case to verify that all Phoenix files have been installed in the correct locations and that they have not been modified. The other two base test cases verify that 1) two CSV files known to match will correctly be passed when compared on the user’s system and 2) two CSV files known to differ will correctly be failed when compared on the user’s system. These two test cases verify that the Validation Suite tool is functioning as intended.

Note:The Phoenix Model Object (NLME engine) can only run on 64-bit systems, so any test cases for the NLME will have a status of “not applicable” (N/A) on 32-bit systems.

NLME test cases

Framework Tests

Name

Test Objective

PHX Installation

Proper installation of all files in the correct location.

CSV File Comparison Success

Correct identification of identical CSV files by the comparison tool.

CSV File Comparison Failure

Correct identification of differing CSV files by the comparison tool.

NLME Tests

Name

Test Objective

NLME BQL LLOQ PK 1Cmpt IV Bolus Laplacian

NLME BQL with censor column and BQL with static LLOQ, for 1-cmpt PK model with IV bolus dose and multiplicative error, using Laplacian engine.

NLME Count NegativeBino­mial RandomBlocks Lapla­cian

NLME Count model with correlated random effect blocks, using LL statement for negative binomial count model and Laplacian engine.

NLME Event 1Cmpt 1stOrderAbsorp ImaxHaz­ard QRPEM

NLME Time-To-Event model, using joint PK 1cmpt 1st-order absorption model and time-to-event model, with hazard described by Imax model, using QRPEM engine

NLME Indirect 1Cmpt 1stOrder StimLimitBuildup FOCE ELS

NLME indirect response built-in model, with 1cmpt 1st-order absorption PK model and limited stimulation of buildup, with multiplicative error, using FOCE-ELS engine

NLME Indirect 1Cmpt IV InhibLimitLoss Effect FOCE ELS

NLME indirect response model, with 1-cmpt IV bolus PK model, limited inhibition of loss, and effect cmpt, with multiplicative error, using FOCEELS engine.

NLME Logistic Regression Laplacian

NLME Logistic Regression model, using Laplacian engine.

NLME PD Inhibitory Addi­tiveError FOCE ELS

NLME inhibitory PD model with additive error, using FOCE ELS engine.

NLME PD Inhibitory Addi­tiveError FOCE LB Com­parer

NLME inhibitory PD model with additive error, using FOCE L-B engine, compared with FOCE ELS using Model Comparer.

NLME PD Stimulatory AddPlusMultError FOCE ELS

NLME stimulatory PD model with Add+Mult error model, using FOCE ELS engine.

NLME PD Stimulatory Baseline PowerError Lapla­cian

NLME stimulatory PD model with baseline and power error model, using Laplacian engine.

NLME PD Stimulatory Mix­RatioError FOCE ELS

NLME stimulatory PD model with Mix Ratio error model, using FOCE ELS engine.

NLME PD Stimulatory Sig­moidal MultError FOCE ELS

NLME stimulatory sigmoidal PD model with multiplicative error, using FOCE ELS engine.

NLME PK 1Cmpt 0Order­Absorption ODE FO IT2S

NLME 1-cmpt graphical PK model with 0-order absorption and multiplicative error, as ODE, using FO and IT2S-EM engines to obtain initial estimates.

NLME PK 1Cmpt 0Order­Absorption ODE Laplacian

NLME 1-cmpt graphical PK model with 0-order absorption and multiplicative error, as ODE, using Laplacian engine.

NLME PK 1Cmpt 1stOrder­Absorption SS FOCE ELS

NLME 1-cmpt PK model at steady-state, with 1st-order absorp­tion and multiplicative error, using FOCE ELS engine.

NLME PK 1Cmpt 1stOrder Absorption Tlag FOCE ELS

NLME 1-cmpt PK built-in model with a lag time, with 1st-order absorption and multiplicative error, using FOCE ELS engine.

NLME PK 1Cmpt IV Bolus IOV Reset QRPEM MAP

NLME 1-cmpt PK model with IV bolus dose, interoccasion covariate, and Reset, using QRPEM engine with MAP Assist.

NLME PK 1Cmpt IV Bolus MDV FOCE ELS

NLME 1-cmpt PK model with clearance parameterization, multi­plicative error, IV bolus dose, and MDV column, using FOCE ELS engine.

NLME PK 1Cmpt IV Bolus MM ODE FOCE ELS

NLME 1-cmpt PK model with IV bolus dose and Michaelis-Menten elimination, as ODE, using FOCE ELS engine.

NLME PK 1Cmpt IV Bolus Nonparametric

NLME 1-cmpt PK model with clearance parameterization, multi­plicative error, and IV bolus dose, using Nonparametric engine.

NLME PK 1Cmpt IV Infu­sion ADDL Cov CorrRan­dom FOCE ELS

NLME 1-cmpt PK model with IV infusion and ADDL dosing, con­tinuous covariate, and correlated random effects, using FOCE ELS engine.

NLME PK 1Cmpt IV Infu­sion QRPEM

NLME 1-cmpt PK model with clearance parameterization, multi­plicative error, and IV infusion dose, using QRPEM engine.

NLME PK 2Cmpt 1stOrder­Absorption Cov FOCE ELS

NLME 2-cmpt PK model with 1st-order absorption, multiplicative error, and a categorical covariate, using FOCE ELS engine.

NLME PK 2Cmpt IV Bolus EliminationCmpt ODE Laplacian

NLME 2-cmpt PK model with elimination compartment (plasma and urine observations) and IV bolus dose, as ODE, using Laplacian engine.

NLME PK 2Cmpt IV Bolus LogAdditiveError FOCE ELS

NLME 2-cmpt PK built-in model with IV bolus dose and log-additive residual error, using FOCE ELS engine.

NLME PK 3Cmpt IV Bolus Micro FOCE ELS

NLME 3-cmpt PK built-in model with micro parameterization, multiplicative error, and IV bolus dose, using FOCE ELS engine.

NLME PKPD 1Cmpt 1stOrderAbsorption Inhibi­tory QRPEM

NLME PKPD model with 1-cmpt 1st-order absorption PK model and inhibitory PD model, with multiplicative error, using QRPEM engine.

NLME PKPD Seq 1Cmpt IV Stim Baseline AddError FOCE ELS

NLME sequential PKPD model with 1-cmpt IV bolus PK model and stimulatory PD model with baseline, with additive error, using FOCE-ELS engine.

NLME Profile PK 2Cmpt IV Bolus

NLME Profile option with 10% and -10% perturbations, for 2-cmpt PK model with IV bolus dose.

NLME Resampling Boot­strap PK 1Cmpt IV Bolus

NLME Bootstrap for 1-cmpt PK model with IV bolus dose, using 100 samples.

NLME RunMPI PKPD 1Cmpt 1stOrderAbsorp Inhibitory QRPEM

NLME Local_MPI_4 execution instead of Local, using test case for NLME PKPD 1Cmpt 1stOrderAbsorption Inhibitory QRPEM, with only the execution location changed. (MPI must be installed and Local_MPI_4 defined, or NLME will use non-MPI.)

NLME Simulation PK 1Cmpt IV Bolus

NLME Simulation for 1-cmpt PK model with IV bolus dose, for 1000 subjects, with simulation tables for observations at speci­fied times and for parameter estimates

NLME Stepwise Shotgun Cov Search PK 1Cmpt

NLME Stepwise and Shotgun Covariate Searches for 1-cmpt PK model with continuous and categorical covariates.

NLME VPC ExplicitBin CovStrat PK 2Cmpt

NLME Visual Predictive Check (VPC) with explicit-centers bin­ning and stratification by categorical covariate, for 2-cmpt PK model with 1st-order absorption

NLME VPC NoBin NoStrat PK 2Cmpt

NLME Visual Predictive Check (VPC) for 2-cmpt PK model with covariate, without binning or stratification.

PHX Desc Stats No Weighting

Descriptive Statistics with no weighting, including confidence intervals, specified number of SD, standard percentiles, and user-defined percentiles.

PHX Desc Stats Weighting

Descriptive Statistics with weighting, including confidence inter­vals and units.

PHX DW Transformation Arithmetic

Data Wizard Transformation with each of the predefined arith­metic transformations.

PHX DW Transformation Baseline

Data Wizard Baseline Transformations including change from fixed value, change from minimum per group, percent change from fixed value, and ratios using minimum per group.

PHX DW Transformation Functions

Data Wizard Transformation to perform inverse, absolute, expo­nential, ln, log10, and square root calculations.

PHX Indiv LM 501

Non-population Phoenix Model with constant linear model.

PHX Indiv MM 301

Non-population Phoenix Model with one compartment, bolus input, and Michaelis-Menten output.

PHX Indiv PD 103

Non-population Phoenix Model with an inhibitory effect E0 model.

PHX Indiv PD 105

Non-population Phoenix Model with Sigmoid Emax model.

PHX Indiv PK 1 Clearance

Non-population Phoenix Model with one compartment, IV bolus input, and first-order output with clearance parameterization.

PHX Indiv PK 1 PD 101

Non-population Phoenix Model with an effect compartment PK/PD link model.

PHX Indiv PK 12

Non-population Phoenix Model with two compartments, first-order input, first-order output, lag time, and with micro-con­stants as primary parameters.

PHX Indiv PK 18

Non-population Phoenix Model with three compartments, IV bolus input, first-order output, and with macro-constants as pri­mary parameters.

PHX Indiv PK 6

Non-population Phoenix Model with one compartment, equal first-order input and output, and with lag time.

PHX Indiv PK 9 Units

Non-population Phoenix Model with two compartments, con­stant IV infusion input, first-order output, and with micro-con­stants as primary parameters, with units for the primary and secondary parameter results.

PHX Ratios and Differ­ences

Ratios and Differences from one input worksheet, from two input worksheets, and using means of non-unique values.

 


Last modified date:6/26/19
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