Weight based dosing
Hi everyone,
I am developing a POP PK model for an anti-infective drug, I am trying to
determine if dosing should be weight based or not. The range of weight in the
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 effect
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% for an
80 kg individual, and increase by 25% for an individual that weights 40 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
indicate that it is not clinically significant and weight based dosing is not
required?
Thanks,
Abdullah Sultan, PhD candidate
University of Florida