fixed dose combination [Bioanalytics]

posted by Ohlbe – France, 2015-03-09 20:00 (3730 d 05:19 ago) – Posting: # 14556
Views: 5,210

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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