List of relevant details to report for publication of PBPK models.

Modeling workflowSuggested information
ObjectivesWhat is the purpose of the model?
Model acceptance criteriaWhat criteria are being used to determine if a model is fit-for-purpose?
What is the clinical relevance of these criteria?
What independent data sets are used for model testing?
Model developmentWas the model built using a PBPK software package? If not, information regarding the model structure, the source of parameters, and their physiologic context should be reported.
What input parameters were used? For recommended parameters to include, see Zhao et al., 2012b
What parameters, if any, were estimated when using parameter estimation or sensitivity analysis?
Are the estimated parameters physiologically plausible?
Are the parameters within the range of previously reported values (if applicable)?
Population demographics (Do the simulated and observed populations and study sizes match?)
Model outcomesComparison of the predicted and observed PK
Do the predictions meet the predetermined model specification criteria?
Model performanceWas sensitivity analysis performed to assess whether model output parameters are sensitive to specific input parameters? (Yes/No)
What are the verified applications of the model?
What is the level of uncertainty in the model components?