Bioequivalence and Bioavailability Forum

Dear Ohlbe,

Thanks for the response.

For qualitative clinical diagnostic assay like Electrochemiluminescence do not fully comply with the USFDA guidance, full calibration curve cannot be generated with each run, as Master calibration curve provided by the kit. In case if we prove the appropriateness of calibration by using QC at different concentrations spanning entire range of study sample concentration. Can this method be used for bioequivalence study?

Thanks & regards,
Avinash