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Is there any model/experience available to do intra-species PK
scaling from adults to infants for antibody drugs?
Specifically, how to scale volume of distribution and clearance if
the antibody is eliminated via FcRn recycling route (t1/2 = ~20 days).
High appreciation for your inputs!
Liang Zhao Ph. D.
Pharmacokinetics-Pharmacodynamics, Clinical Development
MedImmune Inc.
One MedImmune Way
Gaithersburg, MD 20878
Phone: (301) 398-4506
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The following message was posted to: PharmPK
Liang,
I would suggest you apply allometric principles to scale from adults
to children. There is nothing special about the FcRn recycling
process that would invalidate allometry.
Nick
--
Nick Holford, Dept Pharmacology & Clinical Pharmacology
University of Auckland, 85 Park Rd, Private Bag 92019, Auckland, New
Zealand
email:n.holford.aaa.auckland.ac.nz tel:+64(9)373-7599x86730 fax:373-7556
http://www.health.auckland.ac.nz/pharmacology/staff/nholford/
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Dear Zhao,
Only through reading about the pharmacokinetics of one of the
therapeutic antibodies, and if I recall correctly, the volume of
distribution of your antibody should not massively differ from your
native human antibody (most types used therapeutically are IgG) for
adults, children and infants. You can certainly do a search on the
therapeutic antibody PALIVIZUMAB to research the difference in
disposition between adults and infants.
You can also consult with literature articles by J. Balthasar and
colleagues. One of which is a great review that I am listing the
citation for below:
Antibody pharmacokinetics and pharmacodynamics
Journal of Pharmaceutical Sciences
Volume 93, Issue 11, Date: November 2004, Pages: 2645-2668
Evelyn D. Lobo, Ryan J. Hansen, Joseph P. Balthasar
I hope this helps.
Murad Melhem, Ph.D.
Cognigen Corporation
Buffalo, NY
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