Bioequivalence and Bioavailability Forum

Bioequivalence in Japan [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2010-02-03 12:10 (5188 d 14:16 ago) – Posting: # 4698
Views: 3,906

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 (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!

• BE study (test vs. reference in Indian subjects)
  
• Bridging study (Indian subjects vs. Japanese subjects)

Do you like to do that?

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


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Complete thread:

• Japan BE requirement mangurohit 2010-02-02 09:20 [Regulatives / Guidelines] 
  • Brazil's CROs Helmut 2010-02-02 15:03
    • Bioequivalence in Japan mangurohit 2010-02-03 05:21
      • Bioequivalence in JapanHelmut 2010-02-03 11:10
    • Japanese Guideline of Bioequivalence Brus 2021-02-24 16:30
      • Japanese Guideline of Bioequivalence Helmut 2021-02-24 18:07
        • Japanese Guideline of Bioequivalence Brus 2021-02-25 11:46