Method Validation [Bioanalytics]

posted by Loky do – Egypt, 2025-03-13 12:19 (39 d 01:15 ago) – Posting: # 24386
Views: 628

Dears
Appreciate your advice
What are the potential implications of mistakenly designing the QC high at 70% of the upper limit and analyzing study samples based on this? Would re-validation and reanalysis of all samples be required, or could this deviation be accepted by regulatory authorities?

Thanks in Advance
LD

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