Enantioselective assay – really? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-09-27 17:55 (542 d 02:36 ago) – Posting: # 22602
Views: 1,464

Hi qualityassurance,

I agree with Dshah’s post.

From my collection of strange stories: Prior to the 2010 BE-GL a couple of my studies of a certain drug were accepted with an achiral method. Approved in 47 countries. However, since the second condition was unknown, in subsequent studies we used an enantioselective method. It turned out that one enantiomer accounted for >95% of the total AUC.AFAIK, none of the product-specific guidances recommend a chiral assay…

❝ The question is related to product-specific bioequivalence guidance (EMA) for Ibuprofen…


The enantiomeric interconversion of ibuprofen is extremely fast. IMHO, dexibuprofen is a mere marketing joke.

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
22,548 posts in 4,723 threads, 1,606 registered users;
22 visitors (0 registered, 22 guests [including 11 identified bots]).
Forum time: 19:32 CET (Europe/Vienna)

You can’t really say “similar” if it’s the same again you want.
“Similar” means something different.    Anthony Burgess

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