ULOQ [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2017-10-30 10:30  – Posting: # 17947
Views: 5,519

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.

Cheers,
Helmut Schütz
[image]

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

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,883 posts in 4,214 threads, 1,365 registered users;
online 17 (0 registered, 17 guests [including 8 identified bots]).
Forum time (Europe/Vienna): 17:43 CEST

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5