Bioequivalence and Bioavailability Forum • Tlag

Tlag - subtleties [NCA / SHAM]

posted by Helmut – Vienna, Austria, 2010-03-03 14:55 (5587 d 03:22 ago) – Posting: # 4854
Views: 8,891

Dear D Labes,

I agree with or seafaring friend’s post. Make yourself clear that at the LLOQ a bias of ±20 % and a precision of ±20 % is generally acceptable (even higher for ligand binding assays or other difficult methods, if justified). Such a value (12.82>9.6) might be just chance. Now for the stupid part. For the last 30 years I applied a blinded plausibility review – such a value would trigger reanalysis. But according to the new BE-guideline and the drafted bioanalytical GL this procedure is considered blasphemy.
I’m fine with your definition.
No off-the-shelf-software I know of.

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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Tlag - subtleties d_labes 2010-03-03 09:23 [NCA / SHAM]
- Tlag - subtleties ElMaestro 2010-03-03 10:49
  - Tlag - R qualified d_labes 2010-03-03 13:44
- Tlag - subtletiesHelmut 2010-03-03 13:55
  - Tlag - subtleties d_labes 2010-03-03 14:31