Bioequivalence and Bioavailability Forum

LLOQ “low enough”? [Bioanalytics]

posted by jag009  – NJ, 2013-01-11 16:20 (4520 d 16:10 ago) – Posting: # 9827
Views: 8,001

Hi Helmut,

❝ Sounds OK, but didn’t you see no values >LLOQ in ~40% of the subjects?

Sorry typo ... I meant to push down the ULoQ to 100ng/mL (or 150 ng/mL from current 200ng/mL) and lower the LLoQ to below 1ng/ml(Not sure how low yet. As you mentioned I will need to check the chemist first). I think with a 0.25-0.5ng/mL as LLoQ maybe doable.

If 40% of the subjects still show many BLQs with some detectable values not much higher than the LLoQ while the other 1/2 show normal concentration ranges then I don't see how I can justify that the parent compound measurement is deemed reliable for bioequivalence assessment. I don't think I will see this happening with future studies having 2x the dose though...

Thanks
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