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patel_prakash79 ☆ India, 2009-06-17 10:00 (6220 d 18:45 ago) Posting: # 3863 Views: 4,687 |
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Dear All, We would like to conduct the BE study for Russian market. I have tried to get the Russian regulatory guidance for the same. Unfortunately, the regulatory website is found in Russian language only, not available in English version. Could anybody help us in this matter please? I would really appreciate your assistance. Thanks with regards, Prakash |
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Helmut ★★★   Vienna, Austria, 2009-06-17 14:50 (6220 d 13:54 ago) @ patel_prakash79 Posting: # 3866 Views: 3,989 |
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Dear Prakash, you are not alone. Try ![[image]](img/uploaded/image219.png) translate. Unfortunately most documents are given as RAR-archives, PDFs or - even worse - JPGs... I haven't been able to locate the right document(s) yet.— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Dr_Dan ★★ Germany, 2010-11-23 11:18 (5696 d 16:26 ago) @ Helmut Posting: # 6193 Views: 3,635 |
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Dear Helmut, dear all As far as I know for a new application you have to conduct a BE study for the Russian market with a Russian CRO and/or the clinical site must be in Russia. Is this right? I made the same experience that the regulatory website is found in Russian language only, not available in English version. Since the last discussion regarding this issue is more than a year old I would like to know if in the meantime someone got new information and/or the guideline. Any help is much appreciated. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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generapharm ● 2011-02-28 11:27 (5599 d 16:17 ago) (edited on 2011-02-28 11:46) @ Dr_Dan Posting: # 6671 Views: 3,103 |
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Ing. Helmut Schütz