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Dear all,
I would like to explore a PK study using the P-gp efflux blocker (such
as
GF120918, Elacridar) to increase the F% of a drug. While for the in-vivo
studies, which blockers can be used in dog PK studies and what are the
dose
levels? You will be appreaciated if you have any inputs or literatures.
Thanks,
Jack
[First message from Colorado if this gets to you (all) - db]
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Dear Jack
You can refer to
http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/UCM292362.pdf
You can get the inhibitor for P-gp for in vivo study you can convert the
human
dose to animal dose. It will be good if you do it in minimum three doses
of inhibitor. I used Verapamil in rats as P-gp inhibitor.
Thanking you
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