Bioequivalence and Bioavailability Forum

Dear Avinash,

❝ To mimic the clinical sample, we are spiking QCs of drug A in presence of other drug B.

Good precaution.

❝ Is it sufficient to do method validation of method A, proving long term stability in presence of other FDC drug and selectivity experiment.

I would add matrix effects investigations. You can get ion suppression of one drug by the other if they are co-eluted.

❝ Is it required to do complete method validation in presence of other drug?

IMHO no, particularly with co-spiked QCs. One P&A run won't hurt if you want to play it safe.