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Dear Colleagues,
We often use animal PK data from 3 species for allometric
scaling and prediction of human exposure. Typically, animal PK data
is obtained
using different formulations than those used in human studies. How do
you
account/correct for BA differences between non-clinical and clinical
formulations when predicting human exposure? Some colleagues feel that
allometric scaling somehow account for BA differences.
Rostam
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Having run these allometric scaling calculations, a simple correction
or an accommodation for the %F across species cannot be done. Ideally
a uniform formulation as well as physical form would provide you with
an even set of variables, but Fa would be a better measure, but again
dosage in an enhancer excipient versus a HPBCD is the comparison of
apples and oranges, let alone a rat versus human.
Sanjeev Thohan, PhD
Director, DMPK
Exelixis, Inc
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