2019 PharmSci 360
Published quantitative systems pharmacology (QSP) models usually present tables with initial parameter values including their sources as references. Reliability of the sources is rarely evident, and evaluating each reference individually can be an enormous undertaking. The present work builds on a previously introduced methodology (Gulati A, Tannenbaum S. Pharm Sci 360, 2018) and aims to evaluate the reliability of initial parameter values in QSP models, as well as the sensitivity of model outputs to each parameter, thus helping to build confidence in the model predictions. This work provides a bird’s eye view of the reliability and importance of sources of initial parameter values in a QSP model. We propose that this method can become an integral part of the model building process to help establish confidence in a QSP model: for regulatory purposes, for internal cross-functional discussions, and as a standard format for publishing QSP models.