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The following message was posted to: PharmPK
Hi folks,
I was wondering if anyone knew of any direct evidence of the population
approach being specifically utilized during preclinical animal studies,
such as helping to guide initial dosing for first-in-human studies, for
allometric interspecies scaling, or anything along those lines?
Actual references would be greatly appreciated.
Thanks a lot,
Dave J.
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Dear David,
Please find some references listed below that addressed the issues that you
are currently evaluating. I would be happy to forward further information
if you require it. Dr. Holford, Dr. Kimko and myself had some experience in
applying these methodologies to allometric scaling and guiding the selection
of the first dose in human (while at CDDS- Georgetown). We implemented an
interested methodology that took advantage of examining two levels of
variability on the parameters in the allometric regression - a within
species variability term as well as a between species variability term along
with the implementation of the simultaneous solution of the allometric
regression published by Cosson in 1997.
Bies RR, Ko HC, Gobburu J, Burak E, Slusher B, Hilt D, Vornov J, Bradley C,
Bradford C, Sleczka B, Yang W, Peck C. Allometric Scaling of Pre-Clinical
Pharmacokinetic Data to Predict Human Pharmacokinetic Disposition for
NAAL-1, A Novel NAALADASE Inhibitor. AAPS PharmSci suppl 1999;1:4.
Bies RR, Ko HC, Gobburu J, Burak E, Slusher B, MayLu XC, Hilt D, Vornov J,
Bradley C, Peck C. The Relationship of Pharmacokinetic Metrics to Efficacy
in Pre-clinical Rat Middle Cerebral Artery Occlusion (MCAO) Studies for
NAAL-1, a Novel NAALADASE Inhibitor. AAPS PharmSci 1999;1:4.
Bies RR, Ko HC, Gobburu J, Desjardins R, Peck CC. Effective incorporation of
preclinical information into the decisionmaking process for new drug
development: an anonymous case study. Clin Pharmacol Ther 2000;67:2:107
Bies RR, Holford NHG, Karlsson M, Burak E, Kimko HC, Peck CC. A theoretical
value of the allometric exponent may be a suitable alternative to an
unconstrained estimate for describing species differences in distribution
volume and clearance. AAPS '2000 meeting. (AAPS PharmSci).
Iavarone L, Hoke J, Bottacini M, Barnaby R, Preston G. First time in human
for GV196771: Interspecies scaling applied on dose selection. J Clin
Pharmacol 1999;39:560-566.
Lave T, Portmann R, Schenker G, et al. Interspecies pharmacokinetic
comparisons and allometric scaling of napsagatran, a low molecular weight
thrombin inhibitor. J Pharm Pharmacol 1999;51(1):85-91.
Cosson VF. Fuseau E. Efthymiopoulos C. Bye A. Mixed effect modeling of
sumatriptan pharmacokinetics during drug development. I: Interspecies
allometric scaling. [Journal Article] Journal of Pharmacokinetics &
Biopharmaceutics. 25(2):149-67, 1997 Apr.
Best Regards,
Rob
Robert R. Bies Pharm.D.Ph.D.
Assistant Professor of Pharmaceutical Sciences and Psychiatry
University of Pittsburgh
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Use of Population PK Approach in Pre-clinical animal studies - correction
Dear All,
I neglected to include other important contributors (especially Mats
Karlsson) to the studies who was instrumental in the implementation of the
between/within species idea.
Best Regards,
Rob
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Hi!
Yes, there are some data for a neuraminidase inhibitor (RWJ 270201) that is
about to be published in Antimicrobial Agents & Chemotherapy (June or July
issue). Also, for Phase I data, there is a reference for BMS 232632 in the
April 1 issue of Journal of Infectious Diseases. Both have GL Drusano as
first author.
George Drusano
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