Bioequivalence and Bioavailability Forum • Too many runs during pre-study validation

Too many runs during pre-study validation [Bioanalytics]

posted by konkous – Greece, 2011-06-28 15:52 (5477 d 04:18 ago) – Posting: # 7176
Views: 5,296

Dear forum members

During pre-study validation one has to run 30 runs to get only 8 valid. All reasons for the rest of the runs failing are documented and explained. I wonder what would this look like from an auditor's point of view?

Complete thread:

Too many runs during pre-study validationkonkous 2011-06-28 13:52
- Too many runs during pre-study validation Ohlbe 2011-06-28 14:04
  - Too many runs during pre-study validation Helmut 2011-06-29 03:21
    - Too many runs during pre-study validation Ohlbe 2011-06-29 09:59
      - Too many runs during pre-study validation konkous 2011-06-29 10:46
        
        Too many runs during pre-study validation Ohlbe 2011-06-29 11:11