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Dear Forum,
Is it required to test the specificity of plasma batches during the
validation study
Is it sufficient to do matrix effect on the differnt 6 batches?
What parameters are needed to study the LCMSMS method specificity?
Thank you for your valuable opinions.
Regards
Bioanalyst LCMSMS
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The following message was posted to: PharmPK
Bioanalyst LCMSMS,
Quoted directly from the guidance document....
Selectivity is the ability of an analytical method to differentiate and
quantify the analyte in the presence of other components in the sample.
For selectivity, analyses of blank samples of the appropriate biological
matrix (plasma, urine, or other matrix) should be obtained from at least
six sources. Each blank sample should be tested for interference, and
selectivity should be ensured at the lower limit of quantification
(LLOQ).
Potential interfering substances in a biological matrix include
endogenous matrix components, metabolites, decomposition products, and
in the actual study, concomitant medication and other exogenous
xenobiotics. If the method is intended to quantify more than one
analyte, each analyte should be tested to ensure that there is no
interference.
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