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avinash ★ India, 2015-03-06 12:18 (3733 d 06:06 ago) Posting: # 14551 Views: 6,755 |
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Dear Members, Please let me know, If a fixed dose combination is administered during clinical phase of BA/BE study, where in, different methods are used for analysis; is it sufficient to check the specificity of the analyte in presence of other drug administered along with long term stability, or should a complete method validation is required with the analyte of interest in presence of other FDC drug in QC samples. |
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Ohlbe ★★★ France, 2015-03-09 20:00 (3729 d 22:25 ago) @ avinash Posting: # 14556 Views: 5,209 |
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Dear Avinash, Selectivity is a must, of course. Long term stability in matrix is required by the EMA guideline (and by the FDA through '483s), though there is a lot of debate around the scientific basis for this. I would also suggest to check there is no matrix effect issue (ion suppression form analyte A due to analyte B, and vice-versa). I think having one run for precision and accuracy for each analyte in presence of a high concentration of the other analyte would also be good. — Regards Ohlbe |
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avinash ★ India, 2015-04-21 10:17 (3687 d 09:08 ago) @ Ohlbe Posting: # 14727 Views: 4,526 |
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Dear Ohlbe, Thanks for the response. Regards, Avinash |
Ing. Helmut Schütz