Duplicate LLOQ and ULOQ [Bioanalytics]

posted by Helmut Homepage – Vienna, Austria, 2020-05-27 16:30 (146 d 05:48 ago) – Posting: # 21484
Views: 4,347

Dear Ohlbe,

» Most frequent: use the first result only. If, and only if it fails (more than 20% deviation at the LLOQ, 15% at the ULOQ): exclude it and use the second. The aim being of course to avoid having to truncate the curve in case of failure.
»
» I see this less and less often. Not sure why (guess: some FDA inspectors did not like it).

Count me in. If you analyzed duplicates, use them.

Dif-tor heh smusma 🖖
Helmut Schütz
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