List of relevant details to report for publication of PBPK models.
| Modeling workflow | Suggested information |
|---|---|
| Objectives | What is the purpose of the model? |
| Model acceptance criteria | What 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 development | Was 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 outcomes | Comparison of the predicted and observed PK |
| Do the predictions meet the predetermined model specification criteria? | |
| Model performance | Was 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? |