Fig. 2.

Decision tree for the verification and optimization of food effect projections using PBPK. This decision tree was utilized by all modelers working on this initiative to verify and, if necessary, optimize their models using an aligned and consistent approach. Confidence categories were defined based on the outcome of this workflow after an independent review of the model outcome and verification. A summary of the outcome of PBPK modeling based on this decision tree for the 30 compounds is provided in Table II