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Kindly advice on those two issues:
At our facility we faced a odd case where some pre dose samples had an
interfering peak of >5% of the Cmax within it's respective analytical
run. These pre dose concentrations were at the same time below the
LLOQ. Kindly advice how to handle this case, and would the statement
mentioned below as stated be considered correct?
"Any interference less that the LLOQ detected in the zero standard
sample of the volunteers should not be repeated even if is more than
the 5% of the Cmax of the phase, since the value obtained is not
accurate and precise":
Question # 2
Doesn't the above mentioned case indicate a problem in the method, or
in the analysis of that specific drug it self?
Quality Unit Manager
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The following message was posted to: PharmPK
1) Did you rule out carry over
2) Silly, but were the subjects exposed to the analyte from a previous
3) If the response is
4) How extensive was the survey of naive samples, did it include male/
female samples? were samples from fasted, non fasted or pre or post
prandial. Was the LOD calculated ?
5) Is the peak identical (MS/DAD) to the analyte?
6) Is there an endogenous analog
Ed O'Connor, Ph.D.
Matrix BioAnalytical Laboratories
25 Science Park at Yale
New Haven, CT 06511
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