Bioequivalence and Bioavailability Forum • Experiences with EU submissions

Experiences with EU submissions [Bioanalytics]

posted by Helmut – Vienna, Austria, 2013-01-10 17:56 (4919 d 03:00 ago) – Posting: # 9819
Views: 8,930

Hi John,

❝ […] What is your definition of reliable in that case? LoQ not low enough? Similar to my case where almost 1/2 the subjects have almost all BLQ values in their profiles?

Mainly LOQ. In another case the LOQ was low enough but we had to deal with an endogenous compound. Sampling an entire blank profile showed that the values were (very, very) highly variable. Subtracting lead no nonsense.

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Helmut Schütz

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Complete thread:

FDA definition of non-accurately and reliably jag009 2013-01-09 22:20
- Experiences with EU submissions Helmut 2013-01-10 14:03
  - Experiences with EU submissions jag009 2013-01-10 16:36
    - Experiences with EU submissionsHelmut 2013-01-10 16:56
      - Experiences with EU submissions jag009 2013-01-10 20:07
        
        LLOQ “low enough”? Helmut 2013-01-10 20:46
        
        LLOQ “low enough”? jag009 2013-01-11 15:20
        
        LLOQ “low enough”? Ohlbe 2013-01-11 19:16
        
        LLOQ “low enough”? jag009 2013-01-11 20:14