Bioequivalence and Bioavailability Forum • Ibuprofen product-specific bioequivalence guidance EMA

qualityassurance
★

2021-09-26 09:45
(1114 d 21:28 ago)

Posting: # 22599
Views: 3,484

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

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.

dshah ★★ India, 2021-09-27 12:22 (1113 d 18:51 ago) @ qualityassurance Posting: # 22600 Views: 2,925	Ibuprofen product-specific bioequivalence guidance EMA Post reply
	Dear qualityassurance! Kindly follow the final product specific bioequivalence guidance. Previously the sponsor may have followed draft guidance, but on current time it is recommended to follow final guidance. Regards, Dshah

Helmut
★★★

Vienna, Austria,
2021-09-27 16:52
(1113 d 14:22 ago)

@ qualityassurance
Posting: # 22601
Views: 2,884

Undeliverable e-mail

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Hi qualityassurance,

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Helmut
★★★

Vienna, Austria,
2021-09-27 17:55
(1113 d 13:18 ago)

@ qualityassurance
Posting: # 22602
Views: 2,805

Enantioselective assay – really?

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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.

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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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qualityassurance ★ 2021-10-12 17:15 (1098 d 13:59 ago) @ Helmut Posting: # 22626 Views: 2,589	Enantioselective assay – really? Post reply
	Dear Helmut and dshah, Thank you for your valuable recommendations. Dear Helmut, Noted the point related to undeliverable email. Regards