ULOQ [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2017-10-30 09:30  – Posting: # 17947
Views: 5,664

Hi Anand,

» In our Pivotal BE Study ULOQ was observed, whether we should exclude from PK?
» After Dilution also it found ULOQ.
» Method should be redeveloped or revalidated?

Perform a partial validation with a higher dilution. If passing the usual criteria for A&P, re-analyse the sample(s) with high concentrations.

» If included,What justification we should provide to Regulatory Agency?

IMHO, that’s not possible.

Helmut Schütz

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

Complete thread:

 Admin contact
20,122 posts in 4,245 threads, 1,383 registered users;
online 9 (1 registered, 8 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 12:35 UTC

Genius is that which forces
the inertia of humanity to learn.    Henri Bergson

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