Bioequivalence and Bioavailability Forum • LLOQ “low enough”?

LLOQ “low enough”? [Bioanalytics]

posted by jag009 – NJ, 2013-01-11 21:14 (4520 d 11:24 ago) – Posting: # 9831
Views: 7,815

Thanks Ohlbe,

The lab that I am working with said their MV with 1ng/mL - 200ng/mL is acceptable but they didn't elaborate. It kind of troubles me because I have existing data (they ran a reference vs reference study for me) to state my concerns to them. Granted that I did the study at 200 mg and the submission studies will be 400 mg. Anyhow I am waiting for their reply.

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 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