Back to the Top
Dear all,
I have to perform analysis of study samples in 10 tissues of eye.
Do i need to do full Valiadation in all the tissues or need to perform some stability experiment.
What here we feel the we need to perform full validation as samples are in 10 different matrix.
I want to know experts opinion.
Regards
Vishal Shah
Back to the Top
VIshal,
It depends on whether you are running the study GLP or not. You may be able to get by with a cross validation using a Low, medium and high concentration to show matrix effects. Please be more specific for specific answers.
-- Sanjeev Thohan, PhD
SARx Consulting
SARxconsult.aaa.Gmail.com
http://www.linkedin.com/in/sanjeevthohan
Back to the Top
The following message was posted to: PharmPK
Hi Vishal
Depends what the focus is. If the study is for regulatory submission you
may have to apply all prerequisites that apply for bio-analytical method
validation but if it is academic oriented the intensity of validation may
differ. The most important steps would be to determine the recovery and
stability of your compound in the matrix homogenate. Typically, the process
by which you intend to homogenize the test tissues should be used to prepare
homogenates from the control tissue that is free of the analyte of interest.
There are two ways to spike the controls (a) either you spike the drug on to
the blank tissue and let it incubate at room temperature for 10-15 mins and
then homogenize the contents in the way the way you normally would or (b)
homogenize the tissue and then spike the drug into the homogenate and let it
incubate at R.T. In both scenarios you may have to be aware of keeping the
weight of the wet tissue constant to the final volume of the homogenate
prepared (i.e. if you are trying to prepare 5% w/v of the homogenate you may
have to be consistent throughout). I feel that the second process (b) is
better than (a) based on my past experience. Another emerging technique is
mass spectrometry imaging that is being used to a certain degree to quantify
analytes in tissue sections using MALDI but may not be applicable to your
case.
Manish
Manish Issar, Ph.D
Project Manager
Applied Biopharmaceutics, LLC
2010 Cascade Drive
Corona, CA 92879
Back to the Top
10 diff tissues=10 diff validations
--
Edward F. O'Connor
78 Marbern Drive
Suffield, Ct 06078-1533
[The archive has been updated and indexed - db]
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "Assay validation for tissue samples" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)