Bioequivalence and Bioavailability Forum

Extrapolation <LLOQ or >ULOQ [Bioanalytics]

posted by Helmut  – Vienna, Austria, 2007-10-23 21:09 (6825 d 10:45 ago) – Posting: # 1242
Views: 10,186

Dear Charl!

❝ I didnt express my point correctly,

Oh no, you did. As I already stated, we used the same procedure for many years following exactly your arguments below.

❝ … e.g if my cc range between 1-100 ng/ml, then why not to accept the concentration of 0.8 ng/ml in the unknown samples, thus we already accept the accuracy for the LLOQ in the cc graph for the 20%.

Yes, I know, but the FDA will not accept it in almost all cases, and many other regulators as well…
My recommendation to not extrapolate beyond LLOQ and ULOQ is pure pragmatism – learned the hard way – not science…

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• Dilution integrity pb070681 2007-10-19 07:03 
  • Dilution integrity Ramesh 2007-10-19 07:29
    • Dilution integrity Helmut 2007-10-19 13:45
      • Dilution integrity Charl 2007-10-22 09:09
        • Extrapolation <LLOQ or >ULOQ Helmut 2007-10-22 12:46
          • Extrapolation <LLOQ or >ULOQ Charl 2007-10-23 09:27
            • Extrapolation <LLOQ or >ULOQHelmut 2007-10-23 19:09
  • Dilution integrity pb070681 2007-10-24 07:03
    • Dilution integrity Helmut 2007-10-26 01:32