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).