Assigning occasions to grouped data
Dear all,
I would like to obtain some feedback from the group about how to assign
occasions for the estimation of interoccasion variability (IOV). I have
three oral PK datasets:
1. concentration-time profiles after multiple doses (first dose at
0h; dosing interval of 24h) from 0 to 96h (56 subjects);
2. concentration-time profiles after multiple doses (first dose at
0h; dosing intervals of 6, 8 or 12h) from 0 to 72h (44 subjects); and
3. concentration-time profiles after a single dose (at 0h) from 0
to 24h (20 subjects).
What I would like to do is to combine these three datasets and perform a
popPK analysis. For this purpose, should I define an occasion based on:
a. time (e.g. occasion1 for any samples taken during 0 to 24h;
occasion2 for any samples taken during 24 to 48h; ...);
b. ingested dose (e.g. occasion1 includes PK profiles from 0 to 24h
for dataset #1, PK profiles from 0 to 6h, 0 to 8h or 0 to 12h for
dataset #2, and PK profiles from 0 to 24h for dataset #3; occasion2
denotes PK profiles from 24 to 48h for dataset #1, and PK profiles from
6 to 12h, 8 to 16h or 12 to 24h for dataset #2; ...); or
c. others?
Based on preliminary analysis of dataset #3, the average elimination
half-life is 3h.
Thank you in advance for your kind advice.
Best wishes,
Kok-Yong Seng
DSO National Laboratories
Republic of Singapore