Development of a population model to evaluate the bioequivalent dose of the test formulation
The model-informed assessment followed various iterative steps as described in Figure 2.
Initially, a population pharmacokinetic model that best described the data of the clinical 6MP study was developed and validated. The developed model was then leveraged to perform clinical trial simulations using different doses of the test product to establish the optimal dose that has an identical drug exposure to that of the reference product. The model development, fitting as well as simulations were performed in Pumas® version 2.0 (Maryland, USA).