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Dear List Members,
Could anyone please let me know the criteria for requesting reassays from
pharmacokinetic point of view? i.e. When you receive the data from CROs, do
you have a SOP to help you determine what are the data points you would have
reassayed? Also after you receive the reassay results back, how would you
decide to accept them or not? Are there SOPs regarding determination of PK
outliers as well?
Thanks.
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Hello,
Based on my experience as a Manager of Statistics in a CRO, the FDA
positively insists that you have a SOP to pick your PK repeats.
Whether or not to keep the reassayed values is usually left up to the
SOP(s) in the analytical lab - unless you want a FDA audit. The main
idea is to avoid at all costs, any hint of bias in selecting and
keeping the values.
Best of Luck.
Edmond
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[Two replies - db]
From: "rjain.at.nicholaspiramal.co.in"
Date: Wed, 28 Mar 2001 12:36:44 +0530
To: david.aaa.boomer.org
Subject: Re: PharmPK
There should be definitely a SOP for the repeat analysis as well as the
acceptance criteria for taking the reassayed values.
Ashish Jain
Group Leader-Bioanalytics
Wellquest clinical research
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From: "Edmond B. Edwards"
Date: Thu, 28 Mar 2002 06:56:18 -0600
To: david.-a-.boomer.org
Subject: Re: PharmPK SOP for PK reassays
Oh yes, one more little feature of picking a PK repeat - the FDA (at
least for ANDA submissions) wants to see the calculations with and
without the PK repeats. It has been rumoured that the FDA doesn't want
you to pick PK repeats at all.
Good Luck once again,
... Edmond
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Regarding PK repeats, there needs to be a priori decision tree how you want
to handle re-assay issues when dealing with PK-Outliers. Most of the CROs
and established pharmaceutical companies have established SOPs on dealing
with and reporting repeat assay values. If you don't have an SOP you may be
getting a slap on the wrist. You don't want to send a wrong impression that
by doing few re-assays you are ending up with favorable PK/BE results.
Hope this helps.
Prasad Tata, Ph.D.
Mallinckrodt, Inc.
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)