Back to the Top
The following message was posted to: PharmPK
I have 7 clinical studies ran with consistent Cmax and AUC's.
However, the 8th study showed about a 20% decreases in both metrics.
Can anyone provide some general "questions" as to why that I should
explore.
Much appreciated.
Back to the Top
The following message was posted to: PharmPK
Dear Dee:
First make sure you are indeed having an issue? What
do you mean by consistent; please explain in
statistical terms? 20% decrease when you compare mean
values or .....? Some points to consider: Are these
single center or multicenter trails? Are these trials
looking at the same indication? How patient
demographics are different from site to site? Are
pharmacists involved in preparing the drug? If yes,
are they equally trained and validated? Drug is given
by nurse/physician or patients are responsible for
taking their own drug? Are you analysing your samples
using a central lab or multiple labs? Same PK
protocol? What about PK data analysis itself, same
treatment of all datasets? Compound stability?
Rostam
Back to the Top
The following message was posted to: PharmPK
Everything seems to be the same with all the studies (as you were
discussing below) which is why I pose the question. It just seems odd
that the metrics would change from one IV study to another (with the
same conditions)
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)