Bioequivalence and Bioavailability Forum

Incurred Sample Re-analysis [Bioanalytics]

posted by Helmut  – Vienna, Austria, 2007-07-16 19:38 (6502 d 08:16 ago) – Posting: # 897
Views: 10,269

Dear Charl!

❝ Hi, can any one guide me to any reference where there is any note for doing re-analysis for authentic samples.

I guess you are talking about 'Incurred Sample Re-analysis' (is this really English?)

Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, and R Weiner
Workshop/Conference Report - Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays
The AAPS Journal 2007; 9 (1) Article 4, E30-E42
(currently available at http://www.aapsj.org/articles/aapsj0901/aapsj0901004/aapsj0901004.pdf)

❝ is there any specifications for the amount to be re-analyszed?

At least not in the cited reference.
Canada had a requirement of 15% for many years; but this requirement was removed in 2003.

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Complete thread:

• Re-analysis Charl 2007-07-16 14:52 [Bioanalytics] 
  • Incurred Sample Re-analysisHelmut 2007-07-16 17:38
    • Incurred Sample Re-analysis Ohlbe 2007-07-17 10:16
      • Incurred Sample Re-analysis Helmut 2007-07-17 13:01
        • Incurred Sample Re-analysis Ohlbe 2007-07-17 14:15
          • Incurred Sample Re-analysis Helmut 2007-07-17 16:46
            • Incurred Sample Re-analysis Ohlbe 2007-07-17 22:43
              • Plausibility review? Helmut 2007-07-18 02:49
            • Incurred Sample Re-analysis Jaime_R 2007-07-19 10:41