Bioequivalence and Bioavailability Forum

Dear Members,

We have to perform “Thyroid hormone” assay for BA/BE studies, using “Electrochemiluminescence” method. The method was fully validated by manufacturer.

In this method the calibration curve is generated using the Master calibration curve provided by the kit, hence there is no spiking of calibration standards and quality controls.

Please suggest what would be the additional validation parameters that need to be performed to support the FDA method validation requirement?

Thanks & regards,
Avinash Jain