Handling "Not Reportable" Data [Bioanalytics]

posted by ElMaestro  – Denmark, 2014-11-21 10:53 (3838 d 14:45 ago) – Posting: # 13903
Views: 14,545

Hi Emrah,

❝ I think neglecting that value in PK analysis will be the best practice as ElMaestro advised.


Careful, please. If you are submitting in a territory where outlier detection is the norm then perhaps you can neglect the original value after some number crunching gymnastics. But if you are not submitting in a territory where outliers testing is popular then you would perhaps need to either report the value however wrong it sounds, or, audit and self-inspect the study to see if you can verify that something really went wrong (and you need more than just an unexpected value for that); a verification of a problem would then allow you to report the re-analysed value.
—
Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,670 registered users;
32 visitors (0 registered, 32 guests [including 14 identified bots]).
Forum time: 02:39 CEST (Europe/Vienna)

Far better an approximate answer to the right question,
which is often vague, than an exact answer to the wrong question,
which can always be made precise.    John W. Tukey

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5