ULOQ [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2017-10-30 10:59  – Posting: # 17950
Views: 5,651

Hi Ohlbe,

» You can't exclude subjects or data points because they are ULOQ: the ULOQ result would be the Cmax for that subject. If you exclude the data, you will bias the outcome of the study.

Really? Let’s assume that the subject with concentrations >ULOQ is observed in the last batch and we are already close to the validated long-term stability. Even if we revalidate with a higher dilution, we may exhaust the storage interval – resulting in unacceptable results as well. In such a case we have to exclude the subject.

Helmut Schütz

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

Complete thread:

 Admin contact
20,129 posts in 4,245 threads, 1,384 registered users;
online 12 (0 registered, 12 guests [including 7 identified bots]).
Forum time (Europe/Vienna): 09:25 CET

Be very, very careful what you put into that head,
because you will never, ever get it out.    Thomas Wolsey

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