Bioequivalence and Bioavailability Forum

Hello,

as per ANVISA guidelines, specificity/selectivity of the blank plasma batches shall be evaluated against the response of Aqueous LOQ samples,

we used to evaluate the speficity/selectivity of the blank plasma bathces by using the spiked LOQ samples in accordance 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 evaluates the extraction procedure.

please provide comments/suggestions.

Regards,

Debbie.