Enantioselective assay – really? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-09-27 15:55 (275 d 03:03 ago) – Posting: # 22602
Views: 1,198

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 🖖 [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
22,181 posts in 4,647 threads, 1,572 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time: Wednesday 18:59 CEST (Europe/Vienna)

Nerds don’t just happen to dress informally.
They do it too consistently.
Consciously or not, they dress informally
as a prophylactic measure against stupidity.    Paul Graham

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