First in Human (FIH) PBPK predictions

Authors: Miller N
Software: GastroPlus®
Division: Simulations Plus


An overview of what PBPK is will be provided so that everyone starts from the same level. How PBPK is used will be discussed with a particular focus on FIH PK predictions. Key components of a FIH PK prediction for oral administration will be reviewed: absorption, distribution, metabolism and elimination, plus uncertainty analysis. We will finish with case studies highlighting where PBPK was used to avoid a clinical study and how human efficacious doses can be predicted.

By Neil Miller