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

Too many runs during pre-study validation [Bioanalytics]

posted by Ohlbe – France, 2011-06-28 16:04 (5478 d 09:33 ago) – Posting: # 7177
Views: 4,585

Dear Konkous,

❝ I wonder what would this look like from an auditor's point of view ?

At first sight, simple: garbage. And there is a chance there will not be a second sight.

Unless you can demonstrate that this was just bad luck, and an unfortunate accumulation of various different events totally unrelated to the method itself (in 12 of the 20 runs ?), there is a very large chance that an auditor will consider your method as unreliable. Rather go back to method development.

Regards
Ohlbe

—
Regards
Ohlbe

Complete thread:

Too many runs during pre-study validation konkous 2011-06-28 13:52
- Too many runs during pre-study validationOhlbe 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