Scientific Publications by FDA Staff

Regul Toxicol Pharmacol 2020 Aug;115:104691

PBPK model reporting template for chemical risk assessment applications.

Tan YM, Chan M, Chukwudebe A, Domoradzki J, Fisher J, Hack CE, Hinderliter P, Hirasawa K, Leonard J, Lumen A, Paini A, Qian H, Ruiz P, Wambaugh J, Zhang F, Embry M

Physiologically-based pharmacokinetic (PBPK) modeling analysis does not stand on its own for regulatory purposes but is a robust tool to support drug/chemical safety assessment. While the development of PBPK models have grown steadily since their emergence, only a handful of models have been accepted to support regulatory purposes due to obstacles such as the lack of a standardized template for reporting PBPK analysis. Here, we expand the existing guidances designed for pharmaceutical applications by recommending additional elements that are relevant to environmental chemicals. This harmonized reporting template can be adopted and customized by public health agencies receiving PBPK model submission, and it can also serve as general guidance for submitting PBPK-related studies for publication in journals or other modeling sharing purposes. The current effort represents one of several ongoing collaborations among the PBPK modeling and risk assessment communities to promote, when appropriate, incorporating PBPK modeling to characterize the influence of pharmacokinetics on safety decisions made by regulatory agencies.