## Metadata * initial qc commit: ec95d46b078d6e5fe3def36481a732e458d0a0d2 * git branch: git_status * author: Wes Cummings (wes@a2-ai.com) * [file contents at initial qc commit](https://github.com/A2-ai/ghqctoolkit/blob/ec95d46/Cargo.lock) # NONMEM Model ## NONMEM Model Control Stream - [ ] Correct data files are used in model Correct data, file name and hash: - [INSERT] - [ ] `$INPUT` matches Data columns If columns are ignored, explain which ones (i.e. character columns at the end of a dataset): - [INSERT] - [ ] `IGNORE` statements subset the data correctly `IGNORE` statements that should be there and why: - [INSERT] - [ ] Correct `TIME` and `DV` variables - DV or transformed DV used: [INSERT] - TIME column: [INSERT] - [ ] Number of THETAs in the model match in `$THETA` - [ ] Covariates on appropriate THETA Covariates and the parameters they should be on and functional form: - [INSERT] - [ ] Correct Scale Factor and conversions used What the equation should be and why (e.g. S2 = V2/1000 because dose in mg and conc in ng/mL): - [INSERT] - [ ] ETAs on correct parameters and match labels in `$OMEGA` block - [ ] Residual Error model coded correctly - Confirm error model (i.e., proportional error): [INSERT] - [ ] Description of PK model matches `ADVAN/$DES`. - PK model description (i.e., 2-CMT model with first-order absorption and LAG time): [INSERT] - [ ] If Simulation, SEED included in `$SIM` - [ ] `$EST` method consistent with expectation. - expectation (i.e., FOCE-I): [INSERT] - [ ] `$COV` step included for model runs, include MATRIX ## NONMEM Model Output - [ ] Check Run Number matches the control stream - [ ] Successful `$EST` step - `MINIMIZATION SUCCESSFUL` - Absence of warnings like `MINIMIZATION TERMINATED` or `ROUNDING ERRORS` - Check for any warnings or errors, such as `SIGDIGIT`, `NO. OF FUNCTION EVALUATIONS EXCEEDED`, or any numerical issues that might affect the model - [ ] Successful `$COV` step - Ensure the matrix is positive definite. A non-positive definite matrix may indicate issues with model estimation - [ ] Check parameters are not highly correlated - In the `CORRELATION MATRIX OF ESTIMATE` section, correlation coefficients < 0.95 - [ ] Condition Number < 1000 - Found in the `EIGENVALUES OF THE COVARIANCE MATRIX` section, largest eigenvalue divided by smallest eigenvalue - [ ] List parameters with high shrinkage (> 30%) to flag for analyst/medical writer
Metadata
NONMEM Model
NONMEM Model Control Stream
Correct data, file name and hash:
$INPUTmatches Data columnsIf columns are ignored, explain which ones (i.e. character columns at the end of a dataset):
IGNOREstatements subset the data correctlyIGNOREstatements that should be there and why:TIMEandDVvariables$THETACovariates and the parameters they should be on and functional form:
What the equation should be and why (e.g. S2 = V2/1000 because dose in mg and conc in ng/mL):
$OMEGAblockADVAN/$DES.$SIM$ESTmethod consistent with expectation.$COVstep included for model runs, include MATRIXNONMEM Model Output
$ESTstepMINIMIZATION SUCCESSFULMINIMIZATION TERMINATEDorROUNDING ERRORSSIGDIGIT,NO. OF FUNCTION EVALUATIONS EXCEEDED, or any numerical issues that might affect the model$COVstepCORRELATION MATRIX OF ESTIMATEsection, correlation coefficients < 0.95EIGENVALUES OF THE COVARIANCE MATRIXsection, largest eigenvalue divided by smallest eigenvalue