fixed dose combination [Bioanalytics]
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.
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
Regards
Ohlbe
Complete thread:
- fixed dose combination avinash 2015-03-06 11:18 [Bioanalytics]
- fixed dose combinationOhlbe 2015-03-09 19:00
- fixed dose combination avinash 2015-04-21 08:17
- fixed dose combinationOhlbe 2015-03-09 19:00