Bioequivalence and Bioavailability Forum • Acceptance of standard curve and reanalyzed samples

Acceptance of standard curve and reanalyzed samples [Bioanalytics]

posted by Ken Peh – Malaysia, 2014-03-27 20:14 (4478 d 16:41 ago) – Posting: # 12731
Views: 8,975

Dear All,

Appreciate to have your feedback on the following questions.

Do we have to reject the standard curve if the LLOQ and the standard next to LLOQ are out of the range ? EMEA guideline allows throwing 2 out of 8 standard calibrators. In this case, the criteria is fulfilled ?
When we reanalyze the study samples, what is the criteria to accept the value of reanalyzed sample and reject the initial value ? Can we pick the initial concentration if the difference between the reanalyzed concentration and the initial concentration is less than 20% ?

Thank you.

Regards,
Ken

Complete thread:

Acceptance of standard curve and reanalyzed samplesKen Peh 2014-03-27 19:14
- Acceptance of standard curve and reanalyzed samples Ohlbe 2014-03-31 10:54
  - Acceptance of standard curve and reanalyzed samples Ken Peh 2014-03-31 18:41
  - Acceptance of standard curve and reanalyzed samples Ken Peh 2014-04-01 18:36
    - Acceptance of standard curve and reanalyzed samples Ohlbe 2014-04-01 19:12
      - Acceptance of standard curve and reanalyzed samples Ken Peh 2014-06-23 09:09
        
        Acceptance of standard curve and reanalyzed samples Ohlbe 2014-07-02 23:21

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