Enantioselective assay – really? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-09-27 17:55 (927 d 23:34 ago) – Posting: # 22602
Views: 1,880

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.

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