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satishpsm ☆ India, 2014-11-05 10:29 (3452 d 22:31 ago) Posting: # 13830 Views: 3,159 |
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Dear Friends, Can anybody suggest me the list of countries which requires BE study on their own population and List of countries accepts the BE study conducted on Indian population for registration of generic drug product in their countries. Please share any useful link for reference info would be a great help. — Regards, Satish, Formulation scientist, Novartis, India. |
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priya ☆ India, 2014-11-05 11:50 (3452 d 21:10 ago) @ satishpsm Posting: # 13831 Views: 2,554 |
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Hi Satish, ❝ Can anybody suggest me the list of countries which requires BE study on their own population and List of countries accepts the BE study conducted on Indian population for registration of generic drug product in their countries. Russia, Mexico and Japan preferred to conduct the BE studies in their own population whereas remaining countries usually accepts BE studies conducted in Indian population. Priya. |
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VK ☆ Russia, 2014-11-06 14:35 (3451 d 18:25 ago) @ priya Posting: # 13832 Views: 2,458 |
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Hello all, ❝ Russia, Mexico and Japan preferred to conduct the BE studies in their own population. In fact in Russia you are obliged to run clinical part of BE locally in Russia. So i would not call it "prefer". Sincerely VK |
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Tina ★ India, 2014-11-07 13:12 (3450 d 19:48 ago) @ VK Posting: # 13839 Views: 2,355 |
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Dear all, As with Bioequivalence studies, do regulatory authorities (especially FDA and EU authorities) accept usage of population from a different geographic location for Therapeutic equivalence studies? Are there any limitations to using different subject study population in clinical endpoint study(ies)? Kind regards, Tina |
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Helmut ★★★   Vienna, Austria, 2014-11-07 16:31 (3450 d 16:29 ago) @ Tina Posting: # 13841 Views: 2,329 |
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Hi Tina, please do your homework first (see this post). Hints: ICH’s E5(R1), the associated Q&A-document, and guidelines adopted by the FDA and EMA. — 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 |
Ing. Helmut Schütz