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It is often stated that our current laboratory based models of human
PK are reliably predictive of human PK including clearance and
bioavailability eg Kola and Landis, Nature Rev Drug Discov. 2004 Aug;3
(8):711-5. However this seems to contrast with our enquiries within
the pharma industry where predictivity of human PK ranges from 1 in 2
to 1 in 3 ie allometric scaling etc only predicts human PK in 1 in 2
to 1 in 3 occasions. The situation seems to be even worse for
bioavailability where in vitro models including Caco2 and PAMPA
predict as little as 1 in 4.
In the CREAM trial, which we instigated and conducted with the Dutch
clinic PharmaBioresearch and supported by Roche, Lilly, Servier and
Schering AG the predictivity of microdose PK for clearance and
bioavailability was good even for first pass metabolism drugs such as
midazolam.
Does anyone have in-house data to support which of these views is
nearer the truth? The information could be particularly important in
determining the value of human microdosing studies.
Thanks.
Professor Colin Garner BPharm PhD DSc FRCPath
Chief Executive Officer
--
Xceleron Ltd
York Biocentre
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)