Mappings panels identify how input variables are to be used. Map the data by dragging the dataset from the Data folder to the Setup tab or use the icon in the Setup tab.
Once a dataset is mapped, use the option buttons in the Mappings panels to assign the columns in the dataset to the appropriate context associations. Required context mappings are colored orange.
Note: Context associations change depending on the selected Maximum Likelihood model and on options selected in the Structure tab and Input Options tab.
It is not a requirement to map dosing information in the Main Setup tab. Dose can be mapped in the Main tab if dosing information columns exist in the dataset that contains the dependent variable. Otherwise, Phoenix NLME has other options for inputting dosing information as described in the Dosing Setup tab description in the “Dosing panel” section.
All model types
None: Columns mapped to this context are not included in any analysis or output.
Sort: Up to 5 additional study variables used to sort the output. If more than five are mapped to Sort, the first five will be used. A separate analysis is performed for each unique combination of sort variable values. If a variable is used as a sort, it cannot be re-used as a covariate within a model. For multiple sort variables, the order for displayed results can be set in the Output Sort Order tab. Do not use sort values when pooling data (see “A note about Pooled data” for more information).
ID: Up to 5 categorical variable(s) identifying individual data profiles, such as subject ID and treatment in a crossover study. If more than five are mapped to ID, the first five will be used. Only available in Population modeling.
PK model
A1: The amount of drug administered (Micro, Clearance, or Macro; A for Macro1). Used if Intravenous or Gamma, Inverse Gaussian, or Weibull is selected in the Absorption menu (Structure tab).
Aa: The amount administered to the absorption compartment (Micro, Clearance, Macro or Macro1). Used if First-Order is selected in the Absorption menu (Structure tab).
Time: Relative or nominal dosing times usedNominal or actual time collection points in the study.
CObs: The continuous observations of drug concentration in the blood (i.e., the dependent variable). Character and blank (i.e., missing) values are ignored by the model and thus, only numeric entries are considered. Negative and non-negative values are accepted. Using a graphical model or a textual model allows more than two dependent variables in models.
See the “Time and date variable formatting” section for formatting details.
Emax or Linear model
C: The independent variable that is treated as a covariate during the estimation/simulation process. Although this variable is not required by the system, it is likely needed for modeling since it is assumed to be zero if not mapped. Mapped columns can contain character and numeric values (negative and non-negative) and are displayed in the results as IVAR (“independent variable”). Character values are treated as blanks (i.e., missing information) and therefore, values are backwards or forward extrapolated if there is no prior information.
Note: Due to the special embedded nature of the C variable, the posthoc table is not created in the Graphical mode. If required, it is suggested that an explicit covariate C be added to the covariates list.
EObs: The observed drug effect (i.e., the dependent variable). Character and blank (i.e., missing) values are ignored by the model and thus, only numeric entries are considered. Negative and non-negative values are accepted. Using a graphical model or a textual model allows more than two dependent variables in models.
Linked PK, Emax, Indirect, and Linear models all use some combination of the contexts listed above.
A1 Rate/A1 Duration: The rate/duration of drug delivery when Intravenous, Gamma, Inverse Gaussian, or Weibull is selected in the Absorption menu (Micro, Clearance, or Macro; A Rate for Macro1). The A1 Rate column appears when the Infusions possible? option is checked in the Structure tab. The A1 Duration column appears when both Infusions possible? and Duration? are checked.
Aa Rate/Aa Duration: The rate/duration of drug delivery when Intravenous, Gamma, Inverse Gaussian, or Weibull is selected in the Absorption menu. The Aa Rate column appears when the Infusions possible? option is checked in the Structure tab. The Aa Duration column appears when both Infusions possible? and then the Duration? are checked.
Date: Appears in the Mappings panel when Date? is checked in the Input Options tab. Year, month, and day are in pre-specified format.
CObsBQL: Appears if BQL? is checked in the Structure tab and identifies the dataset column containing the BQL flag for the continuous observation values.
A0Obs: Appears if Elim. Cpt.? is checked in the Structure tab. This is the observed amount of drug in the elimination compartment.
MDV: Appears when MDV? is checked in the Input Options tab. It is used to indicate that there is a missing dependent variable by using a nonzero numeric flag. A zero or blank means that the dependent variable value is present. This flag is optional as the tool recognizes which records contain observed values and which do not. However, it can be optionally used, for example, to exclude observations from certain analyses.A summary of the rules that determine which records are used in Phoenix NLME are as follows:
If a single data sheet (combined dosing and observations), mapped from the Main panel, has a dose and a nonzero observation appearing on the same line, then the nonzero observation is treated as real data and is not ignored. (Except if there is an explicit nonzero MDV entry on the line, in which case the observation is always ignored).
If a dose and an observation of 0 appear together on the same line, then the observation is ignored. (Except for the categorical observation case, where the observation is not ignored, unless there is an explicit MDV entry of 1 on the line).
If the dosing information is mapped from the Main panel, there is no associated dose record, and no MDV entry or no MDV entry greater than zero, then an observation with a value (including a value of zero) is a valid observation.
If the dosing information is entered using the dosing panel (either manually in an internal worksheet or from a file containing dosing information), then the dosing information is not merged in the same line as the observation information, even if the time entries are the same. In this case, all observations will be used unless there is an explicit nonzero MDV flag on the observation line.
SteadyState: Appears when Steady State is checked in the Input Options tab. It is used if the model reaches a steady state of dosing.
ADDL: Appears when ADDL is checked in the Input Options tab and is for the column containing the number of additional identical doses to be given, but not observed. Only numeric values or blanks are accepted in columns mapped to ADDL. A blank value is ignored.
See also:
“Time and date variable formatting” for more details on formatting for the Date context.
The BQL? option description in the Structure tab section for more details on BQL.
The NLME engine used by the Maximum Likelihood Models object can be used for analyzing pooled data. This approach fits one set of model parameters to all individuals in a dataset. There are some requirements that must be met to properly configure a pooled model:
Uncheck the Population checkbox, if it is checked.
Do not map any profile data for individuals. Using profile data causes multiple models to be estimated.
If the model includes differential equations, such as the “deriv” statements in the Pharmacometrics Modeling Language:
Make sure that the data are sorted by individual then by time, so that all the observations for any individual are in consecutive and ascending time order. Then clear the Sort Input? checkbox on the Run Options tab.
Select the Reset? checkbox in the Input Options tab and include a column with an indicator for the initial time.
Dosing information must be placed in the observation data. The Dosing Panel does not function properly for Pooled data.
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