Bioequivalence and Bioavailability Forum

Incurred Sample Re-analysis [Bioanalytics]

posted by Ohlbe – France, 2007-07-18 00:43 (6547 d 03:26 ago) – Posting: # 902
Views: 10,697

Dear HS,

❝ Even if we were able to establish some kind of acceptance criteria, IMHO it would lead to a lot of ‘not reportable’ results.

I think the idea would be rather to report the repeated result the way Canada used to request it: the first value obtained should be used for PK calculations, and there should be a table in the report showing the initial and repeat value for random repeats. Now the question is, what do you do with such a table ?

❝ Consequent concentrations are not independent! IMHO any re-analysis ignoring this fact is just some kind of bureaucracy, but definitely not science.

❝ I always suggest to include two adjacent values, or – if the suspect values is the first/last one in a profile – two succeeding/preceding ones.

I agree with you. We used to do this in a lab where I worked some years ago, but I can't remember seeing it done at any of the labs I have visited since.

Regards
Ohlbe

Complete thread:

• Re-analysis Charl 2007-07-16 14:52 [Bioanalytics] 
  • Incurred Sample Re-analysis Helmut 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-analysisOhlbe 2007-07-17 22:43
              • Plausibility review? Helmut 2007-07-18 02:49
            • Incurred Sample Re-analysis Jaime_R 2007-07-19 10:41