Sequence+Formulation+Period appears in the Model Specification field. Select the Fixed Effects tab, make sure that: In the Model tab below the Setup panel, make sure that:Ĭrossover is selected as the Type of study,Īverage is selected as the Type of Bioequivalence, andĬapsule is selected as the Reference Formulation. Leave Formulation mapped to the Formulation context.
Leave Period mapped to the Period context. Leave Subject mapped to the Subject context. Leave Sequence mapped to the Sequence context. Right-click the Workflow object in the Object Browser and then select New > NCA and Toolbox > Bioequivalence.ĭrag the Data 2x2 worksheet from the Data folder to the Main Mappings panel. Import the file …\Examples\WinNonlin\Supporting files\Data 2x2.CSV. The completed project ( Bioequivalence_2x2.phxproj) is available for reference in …\Examples\WinNonlin.Ĭreate a new project named Bioequivalence_2x2. Drug concentrations in plasma were measured, and the AUClast (area under a curve computed to the last observation) was calculated.ĭata for this example are provided in …\Examples\WinNonlin\Supporting files. Within each sequence group, each subject took both formulations, with a washout period between. Twenty subjects were randomly assigned to one of two sequence groups. Both had a label claim of 25 mg per dosing unit.Ī 2x2 crossover design was chosen for this study. The objective of this study is to compare a newly developed tablet formulation to the capsule formulation that was being used in Phase II studies. Knowledge of how to do basic tasks using the Phoenix interface, such as creating a project and importing data, is assumed.Īnalyzing average bioequivalence of 2x2 crossover study exampleĪnalyzing average bioequivalence of a replicated crossover design exampleĮvaluating individual and population bioequivalence example
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