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The following message was posted to: PharmPK
Dear all,
For regulatry requirements what are the procedure for plasma
calibration
and QC sample preparations ?
whether bulk spiked plasma Calibration and QC standards prior to the
analysis or freshly prepared is recomended ?
Regards
Saji
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Dear Saji,
The expectation for QC samples is to prepare them in bulk and
apportion them into aliquots stored under the same conditions that
samples experience.
Calibration samples are typically prepared fresh, although there is
no requirement for this.
The FDA guidance on method validation, method expectations, and
sample analysis is found at:
http://www.fda.gov/cder/guidance/4252fnl.htm
This is in response to the question about: what are the procedure
for plasma
calibration and QC sample preparations ?
whether bulk spiked plasma Calibration and QC standards prior to the
analysis or freshly prepared is recommended ?
Tom Tarnowski
Thomas L. Tarnowski, Ph.D.
650 692-9296
ttarnowski1.-at-.aol.com
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