ULOQ [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2017-10-30 11:30 (1972 d 07:01 ago) – Posting: # 17947
Views: 7,514

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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz

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

Complete thread:

UA Flag
 Admin contact
22,551 posts in 4,724 threads, 1,606 registered users;
17 visitors (0 registered, 17 guests [including 10 identified bots]).
Forum time: 18:31 CET (Europe/Vienna)

If there is an exception to any rule,
and if it can be proved by observation,
that rule is wrong.    Richard Feynman

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