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Hello,
as per ANVISA guidelines, specificity/selectivity of the blank plasma
batches shall be evaluated against the response of Aquoeus LOQ samples,
we used to evaluate the speficity/selectivity of the blank plasma
bathces by using the spiked LOQ samples in accordane with our in-house
SOP.
we are planning for an ANVISA submission, during the process, do we
need to change our SOP, to include the specificity/selectivity
procedure for ANVISA submission.
i believe, that the evaluation using spiked LOQ is more informative,
as it also evlautes the extraction procedure.
please provide expert comments/suggestions.
Regards,
Debbie.
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Dear Debbie,
In my opinion processed blanks spiked with aqueous LOQ will give more
clear picture about possible interferences to demonstrate selectivity.
Following the above procedure should not negate the results of your
submission.
Regards,
Santosh Tata, BS (Pharm. Sci),
Bioanalytical Laboratory,
Clinsys Clinical Research Ltd,
C-46, Sector-62, NOIDA,
Uttar Pradesh, India.
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Dear Debbie, I Agree with your opinion, Spiking LOQ conc in to blanks
for looking at selectivity and specificity. It would mimic the real
situation (In life sample analysis) instead of putting your 100 % in
to the post extracted blanks. I hope this may help you. Regards Raja
Reddy
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