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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