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Weight based dosing

From: Sultan,Abdullah S <a3bdu3>
Date: Wed, 9 Dec 2015 00:39:31 +0000

Hi everyone,


I am developing a POP PK model for an anti-infective drug, I am trying to d=
etermine if dosing should be weight based or not. The range of weight in th=
e study was 40-100 kg.


Weight was statistically significant for Cl/F but only explained 9% of the =
variability observed for Cl.


I used allometric scaling to describe weights effect on Cl/F and slope effe=
ct of weight was 0.58, and scaled to 60 kg (the median).


Based on the slope effect estimated, AUC is predicted to decrease by 15% fo=
r an 80 kg individual, and increase by 25% for an individual that weights 4=
0 kg compared to a 60 kg individual.


How much should I trust the slope effect determined by my study? and should=
 I rely on it to develop the dosing regimen?

if weight only explained 9% of variability observed with Cl/F, could that i=
ndicate that it is not clinically significant and weight based dosing is no=
t required?





Thanks,

Abdullah Sultan, PhD candidate

University of Florida

Received on Tue Dec 08 2015 - 19:39:31 EST

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