Bioequivalence in Japan [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2010-02-03 11:10 (4577 d 04:17 ago) – Posting: # 4698
Views: 3,463

Dear Mangu

» Kindly provide the reasons (Provided by regulatory body) if you have, why only japanese population is required for the bioequivalence study, for the approval in japan market?

Please :google: (quickly)
Japanese are different in their genotypes of some enzymes, achlororhydria is (much!) more common than anywhere in the world, guidelines call for studies in fast metabolizers only (even in cross-over studies), etc....

» According to ICH E5, Is it not applicable to apply foreign clinical data in japan?

Yes it is applicable, but then you will have to perfom an additional bridging study as well!Do you like to do that?

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
22,302 posts in 4,667 threads, 1,586 registered users;
online 9 (0 registered, 9 guests [including 3 identified bots]).
Forum time: Tuesday 16:28 CEST (Europe/Vienna)

In matters of style, swim with the current;
in matters of principle, stand like a rock.    Thomas Jefferson

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