Bioequivalence and Bioavailability Forum

Dear Members,

With regard to analysis of FDC drugs (Drug A and Drug B). We have two different methods (method A and method B) to analyze the samples, spiked separately.

Since clinical samples contain both the drugs (Drug A and Drug B) and methods are separate for both the drugs spiked individually.

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

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

Or

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

Please opine.

Thanks & regards,
Avinash Jain