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The following message was posted to: PharmPK
Hi all
my question is about study design and the inference we can get out
of it. I am performing preclincal studies of a drug in rats. The
study desing has 10 sampling points (with n=3 per sampling point).
I am collecting two samples from each rat (one cardiac and one
terminal) and the protocol has fixed sampling schedule, that is
from rat 1 the two samples to be withdrawn(0.5h and 24h) are
fixed.
The execution of the study goes like this.
15 rats are randomly selected from our inbred population lot and
randomly divided into a group of 5each. once the grouping is done
rats are selected randomly and marked 1 to 5 for each group(so 3
groups of 5 rats each). post dosing the sampling is performed as
per the protocol.
My question is :
how good the mean sample concentration obtained in such a study
design represent the population or rather what is the validity of
such a mean.
thanking you all in advance.
Vipul Kumar
Senior Research Fellow
Pharmacokinetics and Metabolism Div.,
Central Drug Research Institute
Lucknow- 226 001.
vipul kumar gupta
Pharmacokinetics and
Metabolism Div.
CDRI, LUCKNOW-226001
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The following message was posted to: PharmPK
Hello Vipul
Couple of things that you might want to look into:
1. Site differences in blood sampling.
2. You may want to try nonlinear mixed effects techniques for your data
analysis rather than just focussing on the mean.
Venkatesh Atul Bhattaram
CDER, FDA.
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