Back to the Top
Dear Sir
I would like to thank you for your valuable web site. I have a question
regarding repeat assay in bioequivalence studies. According to FDA
Bioanalytical method validation the assay of any blood, plasma, etc
sample should be repeated in triplicate if the volume of the sample
allows.
Is this applies to the following situation
1. When a technical error observed (no internal standard was added,
double internal standard added)
2. Sudden power failure in the instrument (samples were not analysed at
all)
3. Whole batch not acceptable due to failure of QC (quality control)
samples
Best regards for you all
Isra' Admour, M.Sc
Regulatory Affairs Director, IPRC
Back to the Top
The following message was posted to: PharmPK
My interpretation is that if no value has been generated for a sample
for a clearly identified technical reason, or if a value is rejected for
those reasons, then there is no need for triplicate repeat. It is
actually not really a repeat, since there is no valid first result.
The lab's SOP on acceptance criteria should state that a technical
problem can be cause for rejecting a value, and the technical problem
needs to be clearly documented in the study data.
Thomas L. Tarnowski, Ph. D.
Project Team Leader
Dept. Head (Dep), Drug Metabolism and Pharmacokinetics
Roche Palo Alto
3431 Hillview Avenue, Palo Alto, CA 94304
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)