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dear all,
How we can do a stability of drug in whole blood?
When this stabilty requires in a bioanalytical syudy?
regards,
ashish saxena
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Dear Saxena,
Usually the stability of the drug is tested in serum or plasma under different storage conditions.
Dr Zafar
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You need to work with whole blood with an anticoagulant added, preferably the anticoagulant used in the study. Your stability period should cover the period of time between collection and centrifugation/harvest. You should also mimic the collection handling- are the tubes placed on ice, kept refrigerated or kept at room temperature until centrifugation. How long are they held? After harvest it becomes stability in plasma/serum.
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Ashish-
Often whole blood stability is evaluated during method development and confirmed formally during the method validation. One way is to spike drug into freshly collected whole blood and confirm over time that a constant concentration can be recovered. This may not be straightforward, particularly if there is slow or temperature dependence of penetration of the drug into cells. Another way is to collect a blood sample from a dosed animal and process aliquots over time to plasma.
-Tom
Thomas L. Tarnowski, Ph.D.
Bioanalytical Development
Elan Pharmaceuticals, Inc.
800 Gateway Boulevard
South San Francisco, CA 94080
thomas.tarnowski.-a-.elan.com
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Dear Ashish,
You may find this journal helpful:
Journal of Pharmaceutical and Biomedical Analysis 41 (2006) 207-212
Regards
Muyiwa
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