Bioequivalence in Japan [Regulatives / Guidelines]

posted by mangurohit – India, 2010-02-03 05:21 (4495 d 12:53 ago) – Posting: # 4697
Views: 3,380

Dear Friends,

Hope this mail finds you in pink of your health and spirit.

Further to the response to my query about the approval of generic drug in Japan necessiates Japanese population only, I would like to know than what are the different ethnic factors (or other factors) that differenciate japanese population from others (e.g. Indian Population)?

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?

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

Hope for the quick response.
Mangu Rohit

Edit: Linked to previous thread; see the Policy. [Helmut]

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