avinash
★    

India,
2015-03-06 12:18
(3310 d 19:15 ago)

Posting: # 14551
Views: 5,955
 

 fixed dose combination [Bioanalytics]

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.
Ohlbe
★★★

France,
2015-03-09 20:00
(3307 d 11:33 ago)

@ avinash
Posting: # 14556
Views: 4,593
 

 fixed dose combination

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
avinash
★    

India,
2015-04-21 10:17
(3264 d 22:16 ago)

@ Ohlbe
Posting: # 14727
Views: 3,899
 

 fixed dose combination

Dear Ohlbe,

Thanks for the response.

Regards,
Avinash
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