Fig. 1.

Requirements that will allow a high level of confidence in PBPK predictions for the three broad categories of applications. The placement of these three categories of applications along the value chain is also depicted. ¹The greater the variability and smaller the size of the cohort, the larger the range of the estimated parameter. If this range is close to the entire range of plausible values, the exercise of parameter estimation is rendered less valuable. PK pharmacokinetics, NCE new chemical entity, DDI drug–drug interaction, PBPK physiologically based pharmacokinetics