Back to the Top
Dear all,
I want to have you opinion regarding the bioanalytical re-analysis of
plasma samples for PK reasons. Is it justified to do PK repeats even if
plasma concentrations meet the bioanalytical acceptance criteria?
Thanks in advance,
Samia
Samia Ezzine, D.Pharm, M.Sc, Ph.D
Back to the Top
Yes it is reasonable to repeat samples on the grounds of
being "pharmacokinetic outliers": you need to have an SOP in place
prior to performing any assays.
The SOP will define "pharmacokinetic outliers" and the procedure for
handling repeats including assay value
acceptance and rejection criteria by the source laboratory.
Angus McLean
8125 Langport Terrace,
Suite 100,
Gaithersburg,
MD 20877
Phone 301-869-1009
Back to the Top
The following message was posted to: PharmPK
Samia,
There are accepted rules and procedures for repeats and dealing with
the data.
However we all know that just meeting the rules is often not enough. I
suggest
that we all need to keep in mind that the first imperative is 'good
science' and
if we consider re-analysis is warranted and justified then go ahead and
do it
Dave Vowles
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)