Bioequivalence and Bioavailability Forum

Reporting QCs [Bioanalytics]

posted by Charl – 2007-09-03 12:13 (6864 d 13:46 ago) – Posting: # 1053
Views: 8,637

dear ohlbe

I value your feed back notes

❝ The FDA wants you to demonstrate the precision of your method using real-life samples, not only spiked samples. Meaning that if you want to comply with this requirement you will have to re-assay some of the samples from your study. The idea is to use the results of the first determination for your PK analysis, and have a table somewhere listing the results of whatever you will have done to demonstrate precision on incurred samples.

❝ You do not need to treat these results as per your procedure on repeat analysis to select which result should be reported.

what is the minimum re-analysis points is accepted to demonstrate reproducibility from the whole incurred samples?
re-analysis done in duplicate are enough?
what if my plasma sample volumes does not allow me to do re-analysis for more than twice?


Regards
Charl

Complete thread:

• Reporting Failed QCs Dr. Harish L. Rao 2007-08-30 08:55 
  • Reporting QCs Helmut 2007-08-30 12:05
    • Reporting QCs Ohlbe 2007-08-31 10:46
      • Reporting QCs Charl 2007-09-02 15:11
        • Reporting QCs Ohlbe 2007-09-02 23:50
          • Reporting QCsCharl 2007-09-03 10:13
            • Precision of incurred samples Ohlbe 2007-09-03 10:20
              • Problematic incurred samples guidelines Helmut 2007-09-03 19:49