In 2008, a draft guidance was released on the characterization and application of physiologically-based pharmacokinetic (PBPK) or toxicokinetic (PBTK) models in risk assessment, as part of the IPCS Harmonization Project on approaches for evaluating the safety of chemicals. Following a period of public comment and peer review, WHO has now published the finalised guidance, which covers the use of tissue dosimetry in risk assessment, the characterization and documentation of PBPK models, and the application of these models to risk assessment. A case-study on a theoretical chemical is provided in an Annex.

[World Health Organization (2010). International Programme on Chemical Safety Harmonization Project. Characterization and application of physiologically based pharmacokinetic models in risk assessment. Harmonization Project Document No. 9. Available for download at http://www.who.int/ipcs/methods/harmonization/areas/pbpk_models.pdf online.] {178764}

The above item was taken from the April 2011 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details). 

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