PharmPK Discussion - Repeats for PK reason

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On 17 Feb 2005 at 16:54:37, "Ezzine, Samia" (sezzine.at.neurochem.com) sent the message


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

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On 17 Feb 2005 at 17:35:51, Angusmdmclean.-a-.aol.com sent the message


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

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On 21 Feb 2005 at 10:44:04, Dave Vowles (d.vowles.-a-.ncrl.co.uk) sent the message


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

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