Bioequivalence and Bioavailability Forum

Precision of incurred samples [Bioanalytics]

posted by Ohlbe – France, 2007-09-03 12:20 (6866 d 12:08 ago) – Posting: # 1054
Views: 8,556
(edited on 2007-09-03 18:21)

Dear Charl,

❝ what is the minimum re-analysis points is accepted to demonstrate reproducibility from the whole incurred samples?

That's a question FDA refused to answer, leaving it to your best scientific jugement... They didn't say exactly what they want, how they want it to be presented and how they will interpret it

Regards
Ohlbe

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 QCs Charl 2007-09-03 10:13
            • Precision of incurred samplesOhlbe 2007-09-03 10:20
              • Problematic incurred samples guidelines Helmut 2007-09-03 19:49