Bioequivalence and Bioavailability Forum • Experiences with EU submissions

Experiences with EU submissions [Bioanalytics]

posted by jag009 – NJ, 2013-01-10 21:07 (4917 d 04:49 ago) – Posting: # 9820
Views: 8,971

Thanks Helmut,

Do you consider 1ng/mL LLoQ sufficient with the current state of art equipments? I think it's too high (Sciex 5500+ can do better).

With the drug I am working with, based on pilot data, will be like 120 ng/mL for Cmax (the highest Cmax, the study was 200 mg so assuming 2x200mg). The range now is 1ng/mL - 200 ng/mL. I think I can push down the ULoQ to 100 ng/mL and do dilution for higher conc samples.

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 submissions jag009 2013-01-10 16:36
    - Experiences with EU submissions Helmut 2013-01-10 16:56
      - Experiences with EU submissionsjag009 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