Figure 1.

General components of a PBPK analysis package for submission to regulatory health authorities. Green frame represents the PBPK platform components that undergo qualification; blue frame represents the PBPK components that undergo verification. Model iteration is considered a verification step when new data emerge (i.e., clinical observations) and new learnings are applied to the drug model. The model iteration is an essential step towards verification of the parameters and assumptions that were originally implemented, including newly generated data to confirm prior assumptions and optimize parameters where necessary, a process that is generally accepted as good modeling practice across various areas of modeling and simulation.