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Appendix E: Use of Pharmacokinetics to Extrapolate from Animal Data to Humans
Pages 449-452

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From page 449...
... More recently, compartmental models based on chemical transfer in and out of body organs, or even portions of organs, have been developed to describe and predict relationships between administered dose and biologically effective concentrations of parent compounds or metabolites in critical target tissues. These models, which are based on the anatomy and physiology of mammals and use the vast amount of published comparative physiologic data, are known as physiologically based pharmacokinetic (PBPK)
From page 450...
... PBPK models are useful, because they permit estimation of peak concentrations. Species to Species Species-to-species extrapolation is one of the most useful aspects of PBPK, because all mammals have the same macrocirculatory anatomy and much is known about the comparative dimensions of their physiologic characteristicsorgan volumes, blood flow rates, some clearances, etc.
From page 451...
... However, other aspects can be more complicated, particularly those involving metabolism. For instance, there might be qualitative differences between species, such as the presence or absence of a given enzyme, that would result in a (potentially dose-dependent)


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