Bioequivalence and Bioavailability Forum • Experiences with EU submissions

Experiences with EU submissions [Bioanalytics]

posted by jag009 – NJ, 2013-01-10 17:36 (4521 d 15:23 ago) – Posting: # 9817
Views: 7,979

Thanks Helmut,

When you wrote "We also had pilot studies showing that the methods were not capable of delivering reliable PK-metrics". 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?

John

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 submissionsjag009 2013-01-10 16:36
    - Experiences with EU submissions Helmut 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