Guidance documents and model reporting templates

Guidance on development and use of PBK models has been made available from several sources. Key references for guidance documents are provided below.

A notable problem with reproducibility and re-use of existing models is the lack of adequate information on published models. To overcome this issue model reporting guidelines and templates have been proposed. Links to relevant documents are also provided below.

Model development, use, evaluation and reporting guidelines

• World Health Organisation (2010), IPCS harmonization project document no. 9, 'Characterization and application of physiologically based pharmacokinetic models in risk assessment'.
• United States Food and Drug Administration (2018), 'Physiologically Based Pharmacokinetic Analyses — Format and Content; Guidance for Industry'.
• Tan C et al (2020), Regulatory Toxicology and Pharmacology, 115, 104691, 'PBPK model reporting template for chemical risk assessment applications'.
• OECD Series on Testing and Assessment, No. 331, OECD Publishing, Paris, 'Guidance document on the characterisation, validation and reporting of Physiologically Based Kinetic (PBK) models for regulatory purposes'.
• European Medicines Agency (2019) 'Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation'.
• Bernstein, AS et al, A Model Template Approach for Rapid Evaluation and Application of Physiologically Based Pharmacokinetic Models for Use in Human Health Risk Assessments: A Case Study on Per- and Polyfluoroalkyl Substances (2021), Tox Sci, 182(2), 215–228.