Specificity requirement for FDC and concomitant medication [Bioanalytics]

posted by qualityassurance – 2023-07-07 11:06 (147 d 10:41 ago) – Posting: # 23659
Views: 781

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

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