patel_prakash79
☆    

India,
2008-10-06 14:54
(6475 d 01:58 ago)

Posting: # 2486
Views: 3,895
 

 Russian drug agency [Regulatives / Guidelines]

Dear All,

I would like to upgrade my knowledge pertaining to bioequivalence requirement for various regulatory agencies. Further to this, can anybody have an idea about Russian drug agency? If we want to conduct submission bioequivalence study to this authority, what would be the minimum criteria/standard we should follow?
Your suggestions would be appreciated.

With regards,
Prakash
Ohlbe
★★★

France,
2008-10-06 16:40
(6475 d 00:11 ago)

@ patel_prakash79
Posting: # 2487
Views: 3,662
 

 Russian drug agency

Dear Prakash,

You can try the web site of the Russian agency. Unfortunately only in Russian ! Try Google Translate, or an equivalent ?

If you manage to find a Russian BE guideline, please let us know ! Helmut will add it to the Guidance page.

Regards
Ohlbe
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