Back to the Top
Dear all,
We are involved in Preclinical regulatory toxicokinetic and Phase I &
II clinical sample analysis of New Chemical Entities.
I have a question regarding the randomization of biological samples
along with QCs.
1. Is it mandatory to perform randomization of the samples in
bioanalysis ?
2. What is the regulatory perspective on this issue ?
Thanks in advance
Raja
Back to the Top
Dear Raja,
Regarding the question of a requirement for sample randomization or a
regulatory perspective, for chromatographic assays there is no
regulatory expectation of randomization, and several benefits for a
predetermined ordering. See the recent position paper from the 2006
Crystal City Workshop (published in Jan 2007), which has authorship
from both industry and FDA participants.
Tom
Thomas L. Tarnowski, Ph.D.
Bioanalytical Development
Elan Pharmaceuticals, Inc.
800 Gateway Boulevard
South San Francisco, CA 94080
thomas.tarnowski.aaa.elan.com
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 "Randomization of Tox samples" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)