Bioequivalence user interface

Main Mappings panel
Model tab
Fixed Effects tab
Variance Structure tab
Options tab
General Options tab

The Bioequivalence model object is based on a mixed effects model. For more see “General linear mixed effects model”.

Main Mappings panel

Use the Main Mappings panel to identify how input variables are used in a bioequivalence model. A separate analysis is performed for each profile, or unique level of soft key(s). Required input is highlighted orange in the interface.

None: Data types mapped to this context are not included in any analysis or output.

Sort: Categorical variable(s) identifying individual data profiles, such as subject ID and treatment in a crossover study. A separate analysis is done for each unique combination of sort variable values.

Subject: The subjects in a dataset.

Sequence: The order of drug administration.

Period: The washout period, or the time period between two treatments needed for drug elimination. Only applicable in a crossover study.

Formulation: The treatment and reference drug formulations used in a study.

Dependent: The dependent variables, such as drug concentration, that provides the values used to fit the model.

Classification: Classification variables or factors that are categorical independent variables, such as formulation, treatment, and gender.

Regressors: Regressor variables or covariates that are continuous independent variables, such as gender or body weight. The regressor variable can also be used to weight the dataset.

Input data considerations

Missing data: For population and individual bioequivalence, the application assumes complete data for each subject. If a subject has a missing observation, that subject is not included in the analysis. If the data have many missing observations, consider imputing estimated values to produce complete records per subject. Phoenix does not impute missing values.

Variable name and data limits: See “Data limits and constraints”.

Note:Be sure to finalize column names in your input data before sending the data to the Bioequivalence object. Changing names after the object is set up can cause the execution to fail.