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RegisterSpecificity requirement for FDC and concomitant medication [Bioanalytics]
Hi Karthik,
My opinion is that your validation should mimic the actual study condition. In BE studies of FDC, plasma samples contains all the analytes of interest and hence CC/QC during validation should contain the other analyte at ULOQ concentration or cmax concentration.
What is opinion of other (bioanalytical) experts?
Regards,
qualityassurance
My opinion is that your validation should mimic the actual study condition. In BE studies of FDC, plasma samples contains all the analytes of interest and hence CC/QC during validation should contain the other analyte at ULOQ concentration or cmax concentration.
What is opinion of other (bioanalytical) experts?
Regards,
qualityassurance
Complete thread:
- Specificity requirement for FDC and concomitant medication karthik0210 2023-07-01 08:19 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Specificity requirement for FDC and concomitant medicationqualityassurance 2023-07-07 09:06
- Specificity requirement for FDC and concomitant medication Ohlbe 2023-07-10 09:43
Ing. Helmut Schütz