Ibuprofen product-specific bioequivalence guidance EMA [Regulatives / Guidelines]

posted by qualityassurance – Jordan, 2021-09-26 07:45 (239 d 15:39 ago) – Posting: # 22599
Views: 1,397

Dear Forum members,

The question is related to product-specific bioequivalence guidance (EMA) for Ibuprofen draft and Final.

The former indicates that the method should be enantioselective and the later indicates the opposite. Of course we should consider the final guidance and not the draft.

However, all conditions are fulfilled for (⇒ chiral analytics) and also found some public assessment report where chiral method was used and Pharmacokinetic data were submitted for both enantiomers.

Please suggest, whether we should go for chiral or achiral assay?

Thank you.

Complete thread:

UA Flag
 Admin contact
22,092 posts in 4,630 threads, 1,567 registered users;
online 10 (0 registered, 10 guests [including 9 identified bots]).
Forum time: Monday 23:25 CEST (Europe/Vienna)

There is no adequate defense, except stupidity,
against the impact of a new idea.    Percy Williams Bridgman

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