This report is intended to communicate a framework developed for the extrapolation and integration of in vitro-derived measures of chemical metabolism, including those that define human interindividual variability. It presents instruction on the most useful measures of chemical metabolism constants and guides the proper interpretation of differences in enzyme content, so that risk assessors who summarize these types of data for inclusion in human health risk assessment make optimal use of the available information. Likewise, the demonstration of the approach and data requirements will guide the construction of laboratory research protocols which result in the development of data optimally relevant to informing the true nature of human variability. Finally, this approach is communicated through instruction and demonstration of the approach and framework; it is useful to those who develop and evaluate PBPK models intended to address human variability for risk assessment application.

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