ULOQ [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2017-10-30 11:30 (2659 d 13:53 ago) – Posting: # 17947
Views: 8,640

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
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
23,376 posts in 4,912 threads, 1,662 registered users;
108 visitors (0 registered, 108 guests [including 12 identified bots]).
Forum time: 01:23 CET (Europe/Vienna)

Science is what you know.
Philosophy is what you don’t know.    Bertrand Russell

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