Ezetimibe BE [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-09-30 15:26 (386 d 14:32 ago) – Posting: # 20657
Views: 2,674

Hi ElMaestro,

» "The applicant should document that the enzymatic de-conjugation can be considered quantitative under assay conditions"
» :-D:vomit:

That would be a valid request. Has to be determined in method development & validation. No big deal, since β-glucuronidase is used for decades.

Dif-tor heh smusma 🖖
Helmut Schütz

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

Complete thread:

 Admin contact
21,170 posts in 4,411 threads, 1,474 registered users;
online 5 (0 registered, 5 guests [including 2 identified bots]).
Forum time: Wednesday 05:59 CEST (Europe/Vienna)

But it is in matters beyond the limits of mere rule
that the skill of the analyst is evinced.
He makes in silence a host of observations and inferences…    Edgar Allan Poe

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