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avinash ★ India, 2014-09-16 15:46 (3904 d 08:08 ago) Posting: # 13523 Views: 4,715 |
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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 |
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Ohlbe ★★★ France, 2014-09-17 20:55 (3903 d 02:59 ago) @ avinash Posting: # 13529 Views: 3,765 |
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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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avinash ★ India, 2014-09-18 07:11 (3902 d 16:43 ago) @ Ohlbe Posting: # 13532 Views: 3,719 |
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Dear Ohlbe, Thanks for the reply. Avinash |
Ing. Helmut Schütz