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Alpesh Ramani ☆ Ahmedabad, India, 2009-04-24 15:11 (6277 d 04:45 ago) Posting: # 3607 Views: 3,161 |
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Dear Forum Members, One drug extended release formulation is available in India since more then last 4 years, so considering it as a Old formulation, we can get manufacturing and marketing permission from Local state authority. Not if we want to launch additional strength which is not available worldwide and which is not highest or lowest, it is in between the strengths which are already approved. So, for such a case,is it required to conducting any BE or CT ? — Alps |
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krish3108 ☆ 2009-05-04 12:01 (6267 d 07:56 ago) @ Alpesh Ramani Posting: # 3644 Views: 2,476 |
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Dear Alpesh, The new strength if is in between the highest & lowest strength, then i think so you may have to do a BE and since the strength been not available worldwide you would need to perform a CT. Regards Krish -- Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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Ohlbe ★★★ France, 2009-05-04 13:32 (6267 d 06:25 ago) @ krish3108 Posting: # 3646 Views: 2,522 |
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Dear Krish, When answering messages, please delete anything from the text of the original message which is not necessary in understanding your answer; see also this post and the forum policy. Regards Ohlbe |
Ing. Helmut Schütz