Quality Assurance Protocols for Physiologically Based Pharmacokinetic (PBPK) Models
On this page:
Physiologically based pharmacokinetic (PBPK) models often play an important role in modern chemical risk assessments. By accounting for absorption, distribution, metabolism, and excretion (ADME) of a substance in an organism, they can be used to translate externally applied doses or known exposures into measures of internally delivered doses. Conversely, they can be used to translate internal dose metrics, such as blood concentrations associated with toxicity, into external dose metrics, such as oral reference doses or inhaled reference concentrations. For Toxicological Reviews conducted for the Integrated Risk Information System (IRIS), quantitative scientists at the U.S. Environmental Protection Agency carefully evaluate PBPK models using a documented quality assurance process to decide whether they are adequate for performing dosimetry calculations. In this introductory presentation, we describe the components of the quality assurance protocols applied to PBPK models used in IRIS chemical risk assessments to provide both context and focus for the discussion of quantitative evaluation criteria for PBPK models.