FDC: Method validation [Bioanalytics]

posted by Ohlbe – France, 2014-09-17 20:55 (3903 d 05:08 ago) – Posting: # 13529
Views: 3,767

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.

Regards
Ohlbe

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