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RegisterMethod Validation [Bioanalytics]
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
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
Complete thread:
- Method ValidationLoky do 2025-03-13 11:19 [Bioanalytics]
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- HQC concentration Ohlbe 2025-03-14 17:13
Ing. Helmut Schütz