Bioequivalence and Bioavailability Forum

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.

• In 2013 Swissmedic asked for BE of the sum of the enantiomers “in order to compare with previous submissions”. Changed the CI in the second decimal…
  
• In 2014 an assessor of an European agency told me that she considers this section of the GL a kind of ‘backdoor’: “If we don’t like [sic!] the study and find no other reason to reject it, we can use the backdoor…”
  
• In 2016 a member of the EMA’s Pharmacokinetics Working Party told me that he hasn’t seen a single study of a racemate with a chiral method.

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.