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Registerfixed 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.
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.
Complete thread:
- fixed dose combinationavinash 2015-03-06 11:18 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- fixed dose combination Ohlbe 2015-03-09 19:00
- fixed dose combination avinash 2015-04-21 08:17
- fixed dose combination Ohlbe 2015-03-09 19:00
Ing. Helmut Schütz